natgillin/translations-raw huggingface dataset:
A new primary end point was defined as Time to clinical cure, i.e. the time to absence of clinical signs. 
Opredeljena je bila nova primarna končna točka: čas do klinične ozdravitve, tj. čas do izginotja kliničnih znakov.
Although on the surface the individual numbers of pigs involved looks small, the applicant has justified that because of the large difference in results between the Doxyprex and control groups the small number of animals still allows a 80% power to be achieved. 
Čeprav morda število vključenih prašičev zgleda majhno, vlagatelj trdi, da velika razlika med rezultati za zdravilo Doxyprex in rezultati iz kontrolnih skupin še vedno omogoča 80-odstotno moč raziskave pri majhnem številu živali.
Store in a dry place. 
Shranite na suhem mestu.
In fact the two positive controls were selected because at that time there were no doxycycline based premix reference products available in Spain. 
Pozitivni kontroli sta bili izbrani, ker takrat referenčnih premiksov na osnovi doksiciklina v Španiji ni bilo na voljo.
Absorption after oral and intramuscular administration shows a high bioavailability. 
Absorpcija po peroralni in intramuskularni uporabi kaže na dobro biološko razpoložljivost.
It was pointed out that even though there are small differences in dosage the mean and maximum steady state plasma concentration are similar. 
Poudaril je tudi, da čeprav pride do majhnih razlik v odmerjanju, sta povprečna ravnovesna plazemska koncentracija in največja ravnovesna plazemska koncentracija podobni.
The main object was to try to ensure intake of the proposed dose of 10 mg/kg b.w. 
Glavni cilj je bil zagotoviti vnos predlaganega odmerka 10 mg/kg TM.
The following calculation can be used to calculate dosage: 
Za izračun odmerka se lahko uporabi naslednja enačba:
Semoline q.s. 
Pšenični zdrob q. s.
MANUFACTURER'S BATCH NUMBER Batch: {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE Serija: {številka}
Following single dose administration, Cmax was 1.70 µg/ml with a Tmax of 6 hours. 
Po zaužitju enkratnega odmerka je bil Cmax 1,70 µg/ml s Tmax 6 ur.
The submitted references supported pharmacodynamics including MIC data (more than 5 years old) and pharmacokinetics of the active substance, doxycycline. 
Predloženi viri podpirajo farmakodinamiko, vključno s podatki o MIK (starimi več kot 5 let), in farmakokinetiko zdravilne učinkovine - doksiciklina.
Doxycycline is a semi-synthetic tetracycline derived from oxytetracycline that acts on the 30S ribosomal bacterial subunit in a reversible union, by blocking the binding of aminoacyl-tRNA (transference RNA) to the mRNA/ribosome complex, avoiding the addition of new amino acids to the growing peptide chain and interfering therefore on the protein synthesis. 
Doksiciklin je polsintetični tetraciklin, pridobljen iz oksitetraciklina, ki deluje na ribosomsko bakterijsko podenoto 30S v reverzni zvezi tako, da blokira vezavo aminoacil-tRNA (prenašalne RNA) na kompleks mRNA/ribosom, pri čemer se izogiba dodajanju novih aminokislin na rastočo peptidno verigo in tako vpliva na beljakovinsko sintezo.
The justification was considered acceptable, but the dosing section of the SPC should be amended to better reflect the use as proposed and documented by the applicant. 
Utemeljitev se šteje za sprejemljivo, vendar je treba besedilo povzetka glavnih značilnosti zdravila spremeniti tako, da bolje odraža način uporabe, ki ga je predlagal in dokumentiral vlagatelj.
The following complete feeding stuffs for pigs can be used for the manufacturing of medicated feeds: 
Za izdelavo zdravilnih krmnih mešanic za prašiče se lahko uporabljajo naslednje popolne krmne mešanice:
It is observed that during the first days of treatment the 300 ppm food incorporation came closest to the recommended dose, but as food consumption picked up this was achieved with 200ppm. 
Ugotovljeno je bilo, da se je v prvih dneh zdravljenja dodajanje 300 ppm v krmo najbolj približalo priporočenem odmerku, ko pa se je vnos krme povečal so priporočeni odmerek dosegli z dodajanjem 200 ppm.
Although the choice of positive controls would not be acceptable when assessed under current standards, the CVMP concluded that the applicant has justified that at the time there were no doxycycline based authorised premix for the proposed indications. 
Čeprav izbira pozitivnih kontrol ne bi bila sprejemljiva, če bi se vrednotila na podlagi trenutno veljavnih standardov, je CVMP zaključil, da je vlagatelj z navedbo, da odobreni premiksi na osnovi doksiciklina za predlagane indikacije v času izvedbe preskušanja niso bili na voljo, podal sprejemljivo utemeljitev.
E-08950 Esplugues de Llobregat (Barcelona) Spain Tel: +34 934 706 270 
E-08950 Esplugues de Llobregat (Barcelona), Španija Tel.: +34 934 706 270
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT 
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
A 40% of the drug is metabolised and largely excreted in faeces (bile and intestinal route), mostly as conjugates microbiologically inactive. 
40 % zdravila se presnavlja in pretežno izloča z blatom (žolč in črevo), večinoma v obliki mikrobiološko neaktivnih konjugatov.
Doxycycline is a broad spectrum antibiotic with bacteriostatic activity that acts by interfering on the bacterial protein synthesis of the sensitive species. 
Doksiciklin je antibiotik širokega spektra z bakteriostatično dejavnostjo, ki vpliva na beljakovinsko sintezo občutljivih vrst bakterij.
In order to obtain a correct dosage, the concentration of the antimicrobial agent should be adjusted taking into account the daily feed intake at the onset of treatment. 
Da bi ugotovili pravilno odmerjanje, je treba koncentracijo antimikrobnega sredstva prilagoditi tako, da upoštevate dnevni vnos krmne mešanice na začetku zdravljenja.
Liquid sorbitol, non-crystallising 
Tekoči sorbitol, nekristalizirajoči Tekoči parafin
According to the Clinical and Laboratory Standard (CLSI) regulation, organisms other than streptococci with MIC values ≤ 4 µg/ml are considered sensitive, at 8 µg/ml intermediate and with MIC values ≥ 16 resistant to doxycycline. 
Glede na predpis Inštituta za klinične in laboratorijske standarde (CLSI) so organizmi (razen streptokokov) z vrednostmi MIC ≤ 4 µg/ml občutljivi, 8 µg/ml srednje občutljivi in ≥ 16 µg/ml odporni na doksiciklin.
It should also be included that the incorporation rate should be based on average food consumption at time of initiating treatment. 
Vključiti je treba tudi besedilo, da mora dodajanje temeljiti na povprečnem vnosu krme ob začetku zdravljenja.
The applicant justifies that the presence of M.hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time. 
Vlagatelj pojasnjuje, da prisotnosti M. hyopneumoniae niso določevali z bakteriološkimi metodami, ker je bilo v času raziskave ta organizem težko osamiti.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
For Time to clinical cure, Doxyprex at 200ppm and at 300ppm groups were cured at 3.2 and 3.33 days respectively compared to the TM550 group at 8.2 days, the Stabox group at 11.75 days and the control group at 13.67 days. 
Glede časa do klinične ozdravitve je bila skupina, zdravljena z zdravilom Doxyprex v odmerku 200 ppm, ozdravljena v 3,2 dneh, medtem ko je bila skupina, zdravljena z odmerkom 300 ppm, ozdravljena v 3,33 dneh v primerjavi s skupino s TM550, ki je bila ozdravljena v 8,2 dneh; skupina, ki je prejemala zdravilo Stabox, je bila ozdravljena v 11,75 dneh, kontrolna skupina pa v 13,67 dneh.
Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter was referred to the CVMP. 
Zadeva je bila skladno s členom 33(4) Direktive 2001/82/ES, kot je spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
E-08950 Esplugues de Llobregat (Barcelona) Spain 
E-08950 Esplugues de Llobregat (Barcelona), Španija
Less emphasis should be put on the standard incorporation of 250 ppm. 
Standardno dodajanje 250 ppm pri „normalnem“ vnosu krme je treba manj poudarjati.
It is active against: Pasteurella multocida and Bordetella bronchiseptica 
Deluje proti: Pasteurella multocida in Bordetella bronchiseptica
In two-by-two analysis, both Doxyprex groups were significantly quicker to cure than the negative control and the positive control groups. 
V analizah 2×2 sta obe skupini, ki sta prejemali zdravilo Doxyprex, statistično hitreje ozdravili v primerjavi z negativno kontrolno skupino in pozitivno kontrolno skupino.
During the MRP the applicant did however explain that the incorporation rates of doxycycline in the feed used in the clinical trial were decided to take into account the variability that would be found in the field in regard to pig body weight and feed consumption. 
Vendar pa je vlagatelj med postopkom medsebojnega priznavanja pojasnil, da so se pri dodajanju doksiciklina v krmo v kliničnem preskušanju odločili upoštevati variabilnost, ki se glede telesne mase prašiča in vnosa krme pojavi na terenu.
Therapeutic concentrations have been detected in watery humor, myocardium, reproductive tissues, brain and mammary gland. 
Terapevtske koncentracije so ugotovili v prekatni vodki, miokardiju, reproduktivnih tkivih, možganih in mlečni žlezi.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Industrial Veterinaria, S.A. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Industrial Veterinaria, S. A.
Provided its lipophilic properties doxycycline is easily distributed in animal tissues, showing volumes of distribution of 0.53 l/kg. 
Zaradi svojih lipofilnih lastnosti se doksicilin zlahka razporedi v tkivih živali, pri čemer je volumen razporeditve 0,53 l/kg.
The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix. 
CVMP je na sestanku 21.-22. junija 2006 za zdravilo Doxyprex 100 mg premiks začel napotitveni postopek po členu 33(4) Direktive 2001/28/ES, kakor je spremenjena.
Based on this information the CVMP agreed that the provided references are not suitable as pivotal evidence of clinical efficacy of the product Doxyprex for the proposed indication and dose regimen for M.Hyopneumoniae 
Na podlagi teh podatkov CVMP soglaša, da predloženi viri niso primerni kot ključni dokaz klinične učinkovitosti zdravila Doxyprex za predlagano indikacijo in režim odmerjanja za M. hyopneumoniae.
Semolinea (declared on labelling as carrier) 
Pšenični zdrob (na oznakah naveden kot nosilec)
The lack of evidence of bacteriological cure should be justified and may affect the wording of the indication. 
Pomanjkanje dokazov bakteriološke ozdravitve je treba utemeljiti in po potrebi prilagoditi besedilo indikacije.
The positive control products were chosen on the basis that they were also medicated premixes, indicated for use in pigs, which contained a single active substance, which had a spectrum of activity inclusive of those organisms causing the proposed indications. 
Pravzaprav sta bili pozitivni kontrolni zdravili izbrani zato, ker sta ravno tako medicinirana premiksa, indicirana za uporabo pri prašičih, in vsebujeta eno samo zdravilno učinkovino, katere spekter aktivnosti vključuje organizme, ki povzročajo predlagane indikacije.
The actual groups of pigs studied were all showing clinical signs. 
V skupinah prašičev, ki so jih dejansko preučevali, so vsi prašiči imeli klinične znake.
Shelf-life after incorporation into pelleted feed: 3 months. 
Rok uporabnosti po vključitvi v peletirano krmo: 3 meseci.
The Applicant has given a full discussion on statistical analyses conducted for the pivotal trial. 
Vlagatelj je predložil popoln opis statističnih analiz, opravljenih v ključnem preskušanju.
The CVMP recommendation is to grant the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs the following suggested indication because a positive risk:benefit analysis has been demonstrated and no potential serious risk has been identified. 
CVMP priporoča odobritev dovoljenja za promet za zdravilo Doxyprex 100 mg/g premiks za medicinirano krmo za prašiče s spodnjo indikacijo, saj je bilo dokazano pozitivno razmerje med tveganji in koristnimi učinki, potencialna resna tveganja pa niso bila ugotovljena.
In the answer to the CVMP question the applicant has not discussed or justified the two doses (200ppm and 300ppm) of Doxyprex applied in the clinical trial. 
Vlagatelj v odgovoru na vprašanje CVMP ni razpravljal o dveh odmerkih (200 ppm in 300 ppm) zdravila Doxyprex, ki sta bila uporabljena v kliničnem preskušanju, niti ju ni utemeljil.
New secondary end points were defined as percentage clinically cured on day 7 relapse and mortality rates. 
Nove sekundarne končne točke so: odstotek klinično ozdravljenih živali na 7. dan ter stopnja ponovitve bolezni in smrtnosti.
TARGET SPECIES Pigs (after weaning) 
CILJNE ŽIVALSKE VRSTE Prašiči (po odstavitvi).
PACKAGE SIZE 1 kg 
VELIKOST PAKIRANJA 1 kg
Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/kg once daily for 5 days are stated as having been authorised since 1985. 
Navaja, da so bili v EU premiksi na osnovi doksiciklina za prašiče pri priporočenih odmerkih 10 mg/kg enkrat dnevno v trajanju zdravljenja 5 dni odobreni od leta 1985.
Medicated feed may then be granulated. 
Potem se lahko zdravilna krmna mešanica granulira.
The premix is only intended to be incorporated into granulated medicated feeding stuffs. 
Predmešanica je namenjena le mešanju v granulirano zdravilno krmno mešanico.
The applicant demonstrated through these references that the product fulfils the criteria for a well-established use application. 
Vlagatelj je preko teh virov dokazal, da zdravilo izpolnjuje kriterije za vlogo na osnovi dobro uveljavljene rabe.
Adequate measures should be taken to avoid powder dissemination during the incorporation of the product to the feed. 
Treba je upoštevati ustrezne ukrepe, da se izognete raztresanju praška med vmešavanjem zdravila v krmno mešanico.
Cross-resistance is frequent between tetracyclines. 
Pri tetraciklinih je navzkrižna odpornost pogosta.
The applicant submitted a target species tolerance study and post marketing pharmacovigilance data to support safety of the product. 
Vlagatelj je v podporo varnosti zdravila predložil raziskavo o toleranci ciljnih živalskih vrst in postmarketinške podatke o farmakovigilanci.
To be supplied only on veterinary prescription 
Izdaja zdravila je le na veterinarski recept.
In the practical situation, the premix is usually fed to pigs showing clinical signs and incontact pigs, therefore this active substance is for controlling the clinical signs of disease. 
V praksi se premiks daje prašičem, ki kažejo klinične znake, in prašičem, ki so bili v stiku, zato je ta zdravilna učinkovina namenjena nadzorovanju kliničnih znakov bolezni.
In feed use 
Uporaba v krmi
Its excretion is carried out through the intestinal mucous and in a lower extent, through bile excretion, resulting in plasmatic clearance values of 1.7 ml/min/kg. 
Njegovo izločanje poteka prek črevesne membrane in v manjši meri prek žolča, pri čemer je vrednost plazemskega očistka 1,7 ml/min/kg.
Esmeralda, 19 4º 08950 Esplugues de Ll obregat (Barcelona, Spain) 
Veterinaria, S.A. Esmeralda, 19 4° 08950 Esplugues de Ll obregat (Barcelona, Španija)
Do not administer in conjunction with bactericidal antibiotics like beta-lactames. 
Zdravila ne dajajte v kombinaciji z baktericidnimi antibiotiki, kakršni so betalaktami.
Pigs (after weaning) 
Prašiči (po odstavitvi)
MARKETING AUTHORISATION NUMBER(S)/ MRP PROCEDURE NUMBER 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET/ ŠTEVILKA POSTOPKA Z MEDSEBOJNIM PRIZNAVANJEM (MRP)
“In Spain during 2001, the in vitro sensitivity to doxycycline has been determined against porcine strains of Pasteurella multocida and Bordetella bronchiseptica resulting in MIC90 values of 0.795µg/ml and 0.053µg/ml respectively.” 
»Leta 2001 so v Španiji določili in vitro občutljivost doksiciklina proti prašičjim sevom bakterij Pasteurella multocida in Bordetella bronchiseptica, pri čemer sta bili vrednosti MIC90 0,795 µg/ml oziroma 0,053 µg/ml.«
In the 5 kg, 20 kg and 25 kg presentations, bags contain an additional intermediate nylon layer. 
Vrečke vsebnikov po 5, 20 in 25 kg vsebujejo dodatno vmesno najlonsko plast.
In case of insufficient feed intake, animals should be treated parenterally. 
Če žival ne poje dovolj krme, jo morate zdraviti parenteralno.
For the second clinical study “ Efficacy of the doxycycline in feed for the control of pneumonia caused by P. multocida and Mycoplasma hyopneumoniae 
Glede druge klinične študije „Učinkovitost doksiciklina v krmi za nadzor pljučnice, ki jo povzročata P. multocida in Mycoplasma hyopneumoniae“
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
Doxycycline is widely distributed throughout the organism due to its physico-chemical characteristics, provided that is highly lipid-soluble. 
Doksiciklin se zaradi fizikalno-kemičnih lastnosti obširno porazdeli v organizmu, pri čemer mora biti zelo topen v lipidih.
The applicant provided evidence of efficacy of the active substance, doxycycline, against M.hyopneumoniae in pigs from published literature and from MIC studies. 
Vlagatelj je predložil dokaze o učinkovitosti zdravilne učinkovine, doksiciklina, zoper M. hyopneumoniae pri prašičih iz objavljenih virov in študij MIK.
Pivotal clinical trial with Doxycyline 10% premix 
Ključno klinično preskušanje doksiciklina 10 % premiks
Avoid handling the product if hypersensitivity to tetracyclines exists. 
Izogibajte se uporabi zdravila, če obstaja preobčutljivost za tetracikline.
The uptake of medicated feed by animals can be altered as a consequence of illness. 
Pri živalih se lahko kot posledica bolezni spremeni vnos zdravilne krvne mešanice s krmo.
In order to establish that Doxyprex is similarly bioavailable to the product Pulmodox 5% Premix, the applicant referred to information from the SPC and the hevra.org website. 
Vlagatelj je za dokaz podobne biološke dostopnosti med zdravilom Doxyprex in Pulmodox 5 % premiks navedel podatke iz povzetka glavnih značilnosti zdravila in spletni naslov hevra.org.
The choice of positive control products and the dosing regiment applied were discussed: 
Obravnavali so izbiro zdravil za pozitivno kontrolo in uporabljeni režim odmerjanja:
The CVMP considers that the fact that no post treatment bacteriological samples were taken mean that bacteriological cure cannot be assumed or claimed. 
CVMP meni, da bakteriološke ozdravitve ni mogoče domnevati ali navajati, ker po zdravljenju niso bili odvzeti bakteriološki vzorci.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH REALISE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
From all this information, a significant potential serious risk for safety or efficacy of Doxyprex, for the treatment or control of clinical signs of porcine respiratory disease caused by P.multocida and B.bronchiseptica cannot be identified. 
Na osnovi vseh teh podatkov ni mogoče določiti pomembnega potencialno resnega tveganja glede varnosti ali učinkovitosti zdravila Doxyprex pri zdravljenju ali nadzorovanju kliničnih znakov bolezni dihal pri prašičih, ki jo povzročata P. multocida in B. bronchiseptica.
METHOD AND ROUTE(S) OF ADMINISTRATION In feed use 
NAČIN IN POT(I) UPORABE Uporaba v krmi.
Care should be taken to avoid contact with the product during its incorporation to the feed as well as during the administration of the medicated feed to the animals. 
Izogibajte se stiku z zdravilom med njegovim vmešavanjem v krmno mešanico in med dajanjem zdravilne krmne mešanice živalim.
Thermosealed bags of a complex film made of polyester external layer, aluminium intermediate layer and polyethylene internal layer that is in contact with the product. 
S toplotnim varjenjem zaprte večplastne vrečke, ki jih sestavlja zunanji poliestrski sloj, vmesni aluminijev sloj in notranji polietilenski sloj, ki je v neposrednem stiku z zdravilom.
No dose confirmation studies appear to have been presented the above mentioned study, therefore it is important that the references provided should present robust evidence for the field efficacy of the product. 
V zgoraj omenjeni raziskavi ni bilo predstavljenih študij potrjevanja odmerka, zato je pomembno, da priloženi viri posredujejo trdne dokaze za učinkovitost zdravila na terenu.
Piglet starter feed I (complete feed up to approx. 20 kg body weight) Piglet starter feed II (complete feed up to approx. 35 kg body weight) Complete feed for fattening pigs up to approx. 50 kg body weight Complete feed for fattening pigs of approx. 50 kg body weight Complete feed for fattening pigs of approx. 35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. 
Začetna krmna mešanica za pujske I (popolna krmna mešanica do približno 20 kg telesne teže) Začetna krmna mešanica za pujske II (popolna krmna mešanica do približno 35 kg telesne teže) Popolna krmna mešanica za rejenje prašičev do približno 50 kg telesne teže Popolna krmna mešanica za rejenje prašičev s telesno težo približno 50 kg Popolna krmna mešanica za rejenje prašičev s telesno težo približno 35 kg Za vmešavanje zdravila v krmno mešanico je treba uporabiti mešalnik s horizontalnim trakom.
Deficiencies in the pivotal clinical trial demonstrating efficacy of the product for the treatment of P.multocida and B. bronchiseptica were compensated for by a discussion of the field data in the literature reference provided. 
Pomanjkljivosti pri ključnem kliničnem preskušanju, ki je pokazalo učinkovitost zdravila pri zdravljenju okužb z P. multocida in B. bronchiseptica, so nadomestili s preučitvijo terenskih podatkov v priloženih virih literature.
In the introduction to the responses the applicant has given a justification for submission of this application on a “well-established use” basis. 
Vlagatelj je v uvodu k odgovorom utemeljil svojo vlogo z argumentom „dobro uveljavljene uporabe“.
After withdrawal of medication, half-life of the terminal phase is of 6 h. It is mainly eliminated through the small intestine that supposes an advantage in relation to the rest of tetracyclines provided that it is not accumulated in the organism when renal function is diminished since it is not its mainly route of elimination. 
Večinoma se izloči prek tankega črevesa, kar je prednost v primerjavi z drugimi tetraciklini, saj se ne kopiči v organizmu, kadar je ledvično delovanje oslabljeno, ker to ni njegova glavna pot izločanja.
All the results show a clear improvement of Doxyprex treated pigs, with no relapses and no deaths, compared to a negative control. 
Vsi rezultati kažejo, da je v primerjavi z negativno kontrolno skupino pri prašičih, ki so jih zdravili z zdravilom Doxyprex, prišlo do očitnega izboljšanja brez ponovitev bolezni in brez smrtnih primerov.
Administration of the product according to the recommended posology results in a maximum plasmatic concentration at steady of 2.0 ± 0.4 µg/ml . 
Po uporabi zdravila po priporočeni shemi odmerjanja je največja stalna koncentracija v plazmi 2,0 ± 0,4 µg/ml.
Do not administer with oxidant substances. 
Zdravila ne dajajte sočasno z oksidanti.
The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P.multocida and B.bronchiseptica. 
Vlagatelj je opravil ključno, kontrolirano, randomizirano, dvocentrično, terensko preskušanje končne formulacije za dokaz učinkovitosti zdravila pri zdravljenju okužb zaradi P. multocida in B. bronchiseptica.