natgillin/translations-raw huggingface dataset:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE
The conditions used in the stability studies are according to the ICH stability guideline. 
Pogoji, uporabljeni v študijah stabilnosti, so v skladu s smernicami stabilnosti Mednarodne konference o usklajevanju (ISH).
PK study, also, revealed no safety issues. 
Študija farmakokinetike prav tako ni razkrila nikakršnih vprašanj glede varnosti.
Critical evaluation 
Odločilno vrednotenje
Considering the dissolution test, both strengths of the test product can be classified as “very rapid dissolving tablets”. 
Ob upoštevanju preskusa raztopitve lahko uvrstimo obe jakosti izdelka med „zelo hitro raztopljive tablete“.
The drug substance is completely and fast dissolved independent of the applied medium. 
Zdravilo se popolnoma in hitro raztopi, ne glede na uporabljen medij.
Bioequivalence 
Biološka enakovrednost
The CHMP assessed the dossier and the available data, including the issue raised by the objecting CMS. 
CHMP je ocenil dokumentacijo in razpoložljive podatke, vključno s problematiko, ki so jo izrazile nasprotujoče zadevne države članice.
No significant changes were observed in 6 months accelerated stability study (40°C/ 75% RH) and up to 5 years controlled room temperature stability study. 
V šestmesečni pospešeni študiji stabilnosti (40°C/75 % relativna vlažnosti) in v do 5 let trajajoči študiji stabilnosti pri nadzorovani sobni temperaturi bistvenih sprememb niso opazili.
Its exact biochemical mode of action as well as its receptor specificity and affinity has not been clarified until now. 
Natančen biokemijski način delovanja ter njegova specifičnost in afiniteta za receptorje do sedaj niso bili razjasnjeni.
Validations of the analytical methods have been presented. 
Predstavljene so bile potrditve analitičnih metod.
Analytical data were submitted and the choice of excipients was justified and their functions explained. 
Predloženi so bili analitični podatki, izbira pomožnih snovi pa utemeljena in njihovo delovanje razloženo.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure. 
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BETAVERT N AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BETAVERT N IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Elimination: Excretion of Betahistine is almost entirely (85 % - 90 %) in the urine within 24 hours Betahistin is excreted almost completely as the major metabolite in the urine. 
Izločanje: betahistin se skoraj v celoti (85 % - 90 %) izloči z urinom; v 24 urah se betahistin praktično popolnoma izloči kot glavni presnovek v urinu.
The conditions for the suitability of this biowaiver have been discussed taking into account: solubility, dissolution, and absorption/permeability. 
Na posvetovanju o pogojih za primernost te bio-opustitve so upoštevali: topnost, raztopitev in absorpcijo/prepustnost.
The CHMP considered the chemicalpharmaceutical documentation and Expert Report, of Betahistine, of sufficient quality in view of the present European regulatory requirements. 
CHMP je ocenil, da so kemijsko-farmacevtska dokumentacija in strokovno poročilo za betahistin zadovoljive kakovosti kar zadeva trenutne evropske zakonodajne zahteve.
Betavert N was approved in EU, on 18 April 2007, during a Mutual Recognition Procedure (MRP) with Germany as Reference Member State (RMS) plus 7 Concerned Member States (CMS): AT, BG, CZ, HU, PL, RO and SK. 
Zdravilo Betavert N je bilo 18. aprila 2007 s postopkom medsebojnega priznavanja odobreno v EU, pri čemer je bila Nemčija referenčna država članica, sedem zadevnih držav članic pa Avstrija, Bolgarija, Češka republika, Madžarska, Poljska, Romunija in Slovaška.
Betahistine is a structural analogue of the endogenous histamine. 
Betahistin je strukturni analog endogenega histamina.
The Benefit-Risk-Assessment is positive. 
Ocena razmerja med koristmi in tveganji je pozitivna.
The MAH has provided documents that set out a detailed description of the system of pharmacovigilance. 
Imetnik dovoljenja za promet je priložil dokumentacijo, ki natančno opisuje sistem farmakovigilance.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The product is considered as bioequivalent to the originator, and the benefit-risk balance is considered positive. 
Izdelek je biološko enakovreden svojemu izvornemu zdravilu, razmerje med koristmi in tveganji pa se šteje kot pozitivno.
The Czech Republic came to the conclusion that the bioequivalence has not been properly demonstrated in vivo because of the choice of the analytical method. 
Češka republika je prišla do sklepa, da biološka enakovrednost zaradi izbrane analitične metode ni bila primerno dokazana in vivo.
This procedure concerns Betavert N, a generic version of betahistine dihydrochloride tablets. 
Ta postopek zadeva zdravilo Betavert N, generično različico tablet betahistin dihidroklorida.
Non clinical aspects 
Neklinični vidiki
Metabolism: Betahistine dihydrochloride is rapidly metabolised in the liver to the inactive major metabolite, 2-pyridylacetic acid and to demethyl-betahistine [2-(2 aminoethylpyridine)]. 
Presnova: Betahistin dihidroklorid se v jetrih hitro pretvori v glavni neaktivni metabolit 2-piridil ocetno kislino in v demetil betahistin [2-(2 aminoetil piridin)].
GmbH & Co. KG Liebigstraße 1 - 2 65439 Flörsheim/Main Germany 
KG Liebigstraße 1 - 2 65439 Flörsheim/Main Nemčija
Betahistine is excreted in breast milk in concentrations similar to those found in plasma. 
Betahistin se izloča z materinim mlekom v koncentracijah, podobnih tistim v plazmi.
Biliary elimination is not a significant route of elimination for the active agent or any of its metabolites. 
Izločanje z žolčem ne predstavlja bistvene poti izločanja zdravilne učinkovine ali katerega od njegovih presnovkov.
Peak plasma concentrations of C14-labelled betahistine dihydrochloride are reached approximately 1 hour after oral administration in fasting volunteers. 
Najvišje plazemske koncentracije C14-označenega betahistin dihidroklorida so pri teščih prostovoljcih dosežene približno 1 uro po zaužitju.
Betahistine is an analogue of histamine, which is indicated in the treatment of vertigo associated with functional disorders of the vestibular apparatus in the context of Meniere's symptom complex. 
Betahistin je analog histamina, ki je indiciran za zdravljenje vrtoglavice, povezane s funkcionalnimi motnjami vestibularnega aparata v okviru kompleksnih simptomov Menierjeve bolezni.
Absorption: following oral administration, betahistine dihydrochloride is rapidly and completely absorbed. 
Absorpcija: po zaužitju se betahistin dihidroklorid hitro in v celoti absorbira.
This was done by a bioequivalence study investigating urine levels of the main metabolite and by supportive in vitro studies, performed in the course of the national authorisation procedure, leading to the conclusion that it is justified to waive for further bioequivalence studies in human volunteers. 
To so dokazali v študiji biološke enakovrednosti, kjer so raziskovali ravni glavnega presnovka v urinu, in s podpornimi študijami in vitro, izvedenimi med nacionalnim postopkom za pridobitev dovoljenja, iz česar so zaključili, da je nadaljnje študije biološke enakovrednosti na prostovoljcih upravičeno opustiti.
The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS. 
Na podlagi biofarmacevtskega klasifikacijskega sistema narejene študije učinkovine betahistina in formulacije betahistina, predstavljene tukaj poleg lastnosti zdravila (terapevtski indeks, varnost in popolna absorpcija) in formulacij (sestava), močno podpirajo opustitev in vivo študij biološke enakovrednosti za zdravilo Betavert N. Poleg tega betahistin izpolnjuje predpisane zahteve za odobritev bio-opustitve, saj spada v skupino visoko topnih in popolnoma absorbiranih spojin - v skladu z razredom I biofarmacevtskega klasifikacijskega sistema.
The CHMP agreed that there were no objections to approval of Betavert N 8 mg and Betavert N 16 mg from a nonclinical point of view. 
CHMP se strinja, da z nekliničnega vidika ugovorov za odobritev zdravil Betavert N 8 mg and Betavert N 16 mg ni bilo.
As betathistine is a widely used, well-known active substance, no further studies are required and the MAH provides none. 
Ker je betahistin široko uporabna, dobro znana zdravilna učinkovina, dodatne študije niso potrebne in jih imetnik dovoljenja za promet z zdravilom ni predložil.
The binding of Betahistine to human plasma proteins has been measured by equilibrium dialysis. 
Vezavo betahistina na beljakovine človeške plazme so merili z ravnotežno dializo.
Efficacy and safety of betahistine dihydrochloride in the treatment of symptoms associated with Menière's disease have been demonstrated in preclinical-and clinical trials. 
Klinična učinkovitost/varnost Učinkovitost in varnost betahistin dihidroklorida pri zdravljenju simptomov, povezanih z Menierjevo boleznijo, sta bili dokazani v predkliničnih in kliničnih preskušanjih.
The pure betahistine dihydrochloride could not reliably quantify in the human body. 
Čistega betahistin dihidroklorida ne moremo zanesljivo oceniti v človeškem telesu.
The bioequivalence between Betavert N and the originator is based on Biopharmaceutics Classification System (BCS) approach (biowaiver). 
Biološka enakovrednost med zdravilom Betavert N in izvornim zdravilom temelji na pristopu biofarmacevtskega klasifikacijskega sistema (bio-opustitev).
The preparation of Betahistine is not recommended for use in children and adolescents due to lack of data on safety and efficacy. 
Zaradi pomanjkljivih podatkov o varnosti in učinkovitosti uporaba betahistina pri otrocih in mladostnikih ni priporočena.
The CHMP asked the MAH to clearly prove the bioequivalence between Betavert N and the originator. 
CHMP je prosil imetnika dovoljenja za promet z zdravilom, naj jasno dokaže biološko enakovrednost med zdravilom Betavert N in njegovim izvornikom.
The RMS considers that the Pharmacovigilance system as described by the MAH fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. 
Referenčna država članica je mnenja, da sistem farmakovigilance, ki ga je opisal imetnik dovoljenja za promet, izpolnjuje zahteve, opisane v zvezku 9A „Pravil, ki urejajo zdravila v Evropski uniji“, in zadostno dokazuje, da ima imetnik dovoljenja za promet z zdravilom storitve usposobljene osebe, odgovorne za farmakovigilanco, in ima potrebna sredstva za obveščanje o kakršnih koli neželenih učinkih, do katerih bi lahko prišlo v Skupnosti ali v tretji državi.
A statement signed by the MAH and the qualified person for pharmacovigilance, indicating that the MAH has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided. 
Priložena je bila tudi izjava, ki sta jo podpisala imetnik dovoljenja za promet z zdravilom in za farmakovigilanco usposobljena oseba, o tem, da ima imetnik dovoljenja za promet z zdravilom storitve usposobljene osebe, odgovorne za farmakovigilanco, in da so bila zagotovljena potrebna sredstva za obveščanje o kakršnih koli neželenih učinkih, ki bi se zgodili v Skupnosti ali v tretji državi.
The solubility of the drug substance and the fast dissolution rate of the drug product were already unquestionably proven. 
Topnost učinkovine zdravila in velika hitrost raztopitve produkta zdravila sta že bili nesporno dokazani.
The determination of 2-Pyridylacetic acid (PAA), the active metabolite of betahistine, from urine samples was not considered as up-to-date method, the measurement of PAA in human plasmas would have considered more appropriate. 
Določanje 2-piridil ocetne kisline, aktivnega presnovka betahistina iz vzorcev urina ne velja za sodobno metodo; merjenje 2-piridil ocetne kisline v človeški plazmi bi bilo bolj ustrezno.
Benefit Risk Assessment 
Ocena razmerja med koristmi in tveganji
The originator product is Betaserc® 8 available in 8 mg tablets. 
Izvorno zdravilo je Betaserc® 8, ki je na voljo kot 8-miligramske tablete.
Distribution: The human volume of distribution of betahistine dihydrochloride is not known. 
Porazdelitev: Volumen porazdelitve betahistin dihidroklorida pri človeku ni znan.
The results of solubility study showed a high solubility of the active substance about a broad pH range. 
Rezultati študije topnosti so pokazali visoko topnost zdravilne učinkovine prek širokega pH spektra.
The CHMP has recommended the granting of the Marketing Authorisation(s) for Betavert N and associated names (see Annex I). 
CHMP je priporočil odobritev dovoljenj(a) za promet z zdravilom Betavert N in z njim povezanih imen (glejte Dodatek I).
Based on these, the CHMP proposed a re-test period of 5 years for betahistine hydrochloride. 
Na podlagi tega je CHMP za betahistin hidroklorid predlagal ponovitev preskusov čez 5 let.
The Marketing Authorisation Holder of the originator is Solvay Pharma B.V. settled in Netherlands. 
Imetnik dovoljenja za promet z izvornim zdravilom je družba Solvay Pharma B.V.
The control tests and specifications for drug product are adequately drawn up. 
Kontrolni preskusi in specifikacije zdravila so bili zadostno predstavljeni.
65439 Flörsheim/Main 
Liebigstraße 1 - 2 65439 Flörsheim/Main Nemčija
The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo. 
Vrednotenje prepustnosti in absorpcije zdravilne učinkovine je bilo povzeto iz študije biološke enakovrdnosti in študije masnega ravnotežja in vivo.
The Marketing Authorisation Holder of Betavert N is Hennig Arzneimittel GmbH & Co.KG 
Imetnik dovoljenja za promet z zdravilom Betavert N je družba Hennig Arzneimittel GmbH & Co.KG.
Pharmacodynamic, pharmacokinetic and toxicological properties of betahistine are well known. 
Farmakodinamične, farmakokinetične in toksikološke lastnosti betahistina so dobro znane.
The absolute bioavailability of betahistine dihydrochloride is not known. 
Popolna biološka razpoložljivost betahistin dihidroklorida ni znana.
The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS). 
Imetnik dovoljenja za promet z zdravilom je dokazal biološko enakovrednost z dvema vrstama podatkov: z in vivo študijo biološke enakovrednosti z merjenjem urina in z in vitro študijami biološke uporabnosti/biološke enakovrednosti na podlagi biofarmacevtskega klasifikacijskega sistema.
Non-clinical pharmacodynamic, pharmacokinetic and toxicological properties of betahistine dihydrochloride are also well known. 
Neklinične farmakodinamične, farmakokinetične in toksikološke lastnosti betahistin dihidroklorida so prav tako dobro znane.
The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration. 
Imetnik dovoljenja za promet z zdravilom je dokazal, da sta po enkratni uporabi zdravili Betavert N (Hennig Arzneimittel GmbH, Nemčija) in izvorno zdravilo Betaserc® 8 (Duphar, VB) biološko enakovredni.
The control tests and specifications for drug substance product were adequately drawn up. 
Kontrolni preskusi in specifikacije učinkovine zdravila so bile zadostno predstavljeni.
The solubility of the drug substance and the fast dissolution rate of the drug product have been proven. 
Topnost učinkovine zdravila in velika hitrost raztopitve zdravila sta bili dokazani.
The active substance Betahistine hydrochloride is described in Ph.Eur. 
Zdravilna učinkovina betahistin hidroklorid je opisana v Evropski farmakopeji.
The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System. 
CHMP je sklenil, da se betahistin dihidroklorid lahko uvrsti v razred I po biofarmacevtskem klasifikacijskem sistemu.
Only traces of desmethylbetahistine dihydrochloride are recovered in the urine. 
Desmetil betahistin dihidroklorid se v urinu nahaja le v sledovih.
The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I. 
CHMP je ob upoštevanju teh podatkov sklenil, da se betahistin dihidroklorid po biofarmacevtskem klasifikacijskem sistemu lahko uvrsti v visoko topni razred I.
Consequently the drug product is eligible for BCS based biowaiver approach. 
Posledično je zdravilo primerno za pristop bio-opustitve po biofarmacevtskem klasifikacijskem sistemu.
In conclusuion, considering the absorption correlated with high permeability, the allocation of betahistine dihydrochloride to BCS Class I is considered justified by the CHMP. 
Za zaključek je CHMP mnenja, da je ob upoštevanju absorpcije v povezavi z visoko prepustnostjo, uvrstitev betahistin dihidroklorida v razred I po biofarmacevtskem klasifikacijskem sistemu utemeljena.
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration 
(Izmišljeno) ime
This summary was last updated in August 2016. 
Povzetek je bil nazadnje posodobljen avgusta 2016.
This does not affect the health or performance of the animal. 
To ne vpliva na zdravje in zmogljivost živali.
EMA/CVMP/193329/2007 EMEA/V/C/000051 
EMEA/CVMP/190433/2007 EMEA/V/C/000051
The vaccine is given into the neck at the front of the shoulder. 
Cepivo se daje v vrat v sprednjem delu ramena.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again. 
Če bolečina ne izgine po več kot 12 urah po zdravniškem pregledu, se je treba ponovno posvetovati z zdravnikom.
The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management. 
Virus v cepivu je bil spremenjen tudi tako, da se cepljene živali ločijo od naravno okuženih živali, kar pripomore k boljšemu obvladovanju bolezni.
In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly. 
Če so živali v prihodnje izpostavljene virusu, se lahko njihov imunski sistem hitreje odzove.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger -this could result in the loss of a finger if prompt medical attention is not given. 
Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst na roki - brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Bovalto Ibraxion večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR for Bovalto Ibraxion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Bovalto Ibraxion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016. 
Ime zdravila je bilo 10. avgusta 2016 spremenjeno v Bovalto Ibraxion.
This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bovalto Ibraxion.
Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection. 
Cepivo lahko povzroči rahel dvig telesne temperature (manj kot 1 C), ki izzveni v manj kot 48 urah po cepljenju.
The injection of Bovalto Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks. 
Injiciranje cepiva Bovalto Ibraxion lahko povzroči začasno reakcijo tkiva na mestu injiciranja, ki lahko traja do treh tednov in redko do pet tednov.
Protection starts 2 weeks after vaccination and lasts for 6 months. 
Zaščita se začne dva tedna po cepljenju in traja najmanj šest mesecev.
The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000. 
Evropska komisija je dovoljenje za promet z zdravilom Bovalto Ibraxion, veljavno po vsej Evropski uniji, izdala 9. marca 2000.
Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment. 
Terenske študije so izvedli pri približno 300 glavah goveda različnih starosti v obeh okoljih, okuženem z virusom IBR in neokuženem.
The withdrawal period for meat and milk from cattle treated with Bovalto Ibraxion is ‘zero' days, which means there is no mandatory waiting time. 
Karenca za meso in mleko goveda, zdravljenega z zdravilom Bovalto Ibraxion, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months. 
Pri govedu, cepljenim s cepivom Bovalto Ibraxion, so se zaščitne ravni protiteles proti virusu IBR pojavile po dveh tednih po cepljenju, zaščita pa je trajala šest mesecev.
Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother. 
Cepijo se teleta starejša od dveh tednov z dvema odmerkoma cepiva v razmiku treh tednov, če od matere niso prejela protiteles proti virusu IBR.
When there are antibodies the vaccine should be given to calves from age 3 months. 
Če so protitelesa prisotna, je treba cepiti teleta v starosti od treh mesecev.
Bovalto Ibraxion is an emulsion containing mineral oil. 
Zdravilo Bovalto Ibraxion je emulzija, ki vsebuje mineralno olje.
When Bovalto Ibraxion is given to cattle the animals' immune system recognises the inactive virus as ‘foreign' and makes antibodies against it. 
Ko goveda prejmejo cepivo Bovalto Ibraxion, imunski sistem živali prepozna neaktivirani virus kot „tujek“ ter začne proti njemu tvoriti protitelesa.
A booster injection is given at 6 month intervals. 
Poživitveno cepivo se daje v šestmesečnih presledkih.
IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing. 
Okužbe z virusom IBR prizadenejo dihalne poti in povzročijo nastanek nosnega izcedka, konjuktivitisa (vnetja oči) in kašlja.
For practical information about using Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Bovalto Ibraxion naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.