FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
English: No adverse reactions were observed after an overdose administration (2 doses) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Croatian: Nakon predoziranja (dvije doze) veterinarsko-medicinskim proizvodom nisu opažene druge nuspojave do onih već spomenutih u dijelu 4.6, osim lokalnih reakcija koje mogu trajati duže (najviše
English: After the primary vaccination course, the duration of immunity lasts for one year.
Croatian: Nakon prvog cijepljenja imunitet traje godinu dana.
English: Veterinary medicinal product subject to prescription.
Croatian: Veterinarsko-medicinski proizvod koji se izdaje na recept.
English: Shake the vial gently and administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Croatian: Nježno promućkajte bočicu veterinarsko medicinskog proizvoda i aplicirajte potkožno jednu dozu (1 mL) sukladno sljedećem režimu cijepljenja.
English: Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years.
Croatian: Nakon dodatnog cijepljenja, godinu dana nakon prvog cijepljenja, iduća cijepljenja mogu se obavljati u intervalima od tri godine.
English: Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti nakon prvog otvaranja pakovanja: primijeniti odmah.
English: Immediate packaging:
Croatian: Unutarnje pakovanje:
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Croatian: Također se mogu opaziti i uobičajeni, prolazni simptomi nakon cijepljenja poput hipertermije (traje 1 do 4 dana), apatije i probavnih smetnji.
English: 102 µg FeLV
Croatian: FeLV 102 µg
English: BG: Република България
Croatian: BG: Република България VIRBAC
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Croatian: Dostupni podaci o neškodljivosti i djelotvornosti pokazuju da se ovo cjepivo može primijeniti pomiješano s FELIGEN CRP ili FELIGEN RCP.
English: Re-vaccinations:
Croatian: Ponovno cijepljenje:
English: Protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Croatian: Kod 73% mačaka, 3 tjedna nakon prvog cijepljenja, uočena je zaštita od trajne viremije.
English: Subcutaneous use (under the skin).
Croatian: Subkutana primjena (potkožno).
English: Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
Croatian: Najmanja količina pročišćenog antigena omotača p45 FeLV: 102 µg
English: CZ: Česká republika
Croatian: CZ: Česká republika VIRBAC
English: Pharmacotherapeutic group: immunologicals for Felidae, inactivated viral vaccines for cats.
Croatian: Farmakoterapijska grupa: imunološki VMP za mačke, inaktivirana virusna cjepiva za mačke ATCvet kod: QI06AA01
English: GR: Ελλάδα
Croatian: GR: Ελλάδα VIRBAC Hellas SA
English: No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nakon predoziranja veterinarsko-medicinskim proizvodom nisu opažene druge nuspojave do onih već spomenutih u dijelu 6, osim lokalnih reakcija koje mogu trajati duže (najviše 5-6 tjedana).
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.
Croatian: Nakon dodatnog cijepljenja, godinu dana nakon prvog cijepljenja, imunitet traje 3 godine.
English: Purified extract of Quillaja saponaria
Croatian: Pročišćeni ekstrakt Quillaja saponaria: Pomoćna tvar:
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed, Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Croatian: Također se mogu opaziti i uobičajeni prolazni simptomi nakon cijepljenja poput hipertermije (traje 1 do 4 dana), apatije (ravnodušnost) i probavnih smetnji (bolovi u trbuhu).
English: VIRBAC Hellas SA
Croatian: CY : Κύπρος VIRBAC Hellas SA
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ
English: Vaccine against feline leukaemia.
Croatian: Cjepivo protiv leukemije mačaka.
English: Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Croatian: U rijetkim slučajevima mogu se javiti bol na dodir, kihanje ili konjuktivitis koji nestaju bez ikakvog tretmana.
English: Minimum quantity of purified p45 FeLV-envelope antigen
Croatian: Najmanja količina pročišćenog antigena omotača p45 FeLV
English: Buffered isotonic solution to
Croatian: Izotonična puferska otopina do:
English: Marketing authorisation holder and manufacturer responsible for the batch release VIRBAC
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
English: Excipients:
Croatian: Inkompatibilnosti:
English: Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Croatian: - prva primjena mačićima starijim od 8 tjedana
English: 1ère avenue 2065 m L.I.D 06516 Carros France
Croatian: 1ère avenue - 2065 m - L.I.D. 06516 Carros Cedex Francuska
English: Read the package leaflet before use Subcutaneous use
Croatian: NAČIN I PUT(EVI) PRIMJENE Pročitati uputu o VMP prije primjene.
English: It is a ‘generic medicine'.
Croatian: To je „generički lijek”.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Croatian: To znači da sadržava iste djelatne tvari i djeluje na isti način kao i „referentni lijek” koji je već odobren u EU pod nazivom Truvada.
English: The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food.
Croatian: Preporučena doza za liječenje ili sprečavanje infekcije virusom HIV-1 je jedna tableta jedanput dnevno, a poželjno je da se uzima s hranom.
English: Emtricitabine/Tenofovir disoproxil Krka received a marketing authorisation valid throughout the EU on 9 December 2016.
Croatian: Lijek Emtricitabine/Tenofovir disoproxil Krka dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 9. prosinca 2016.
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for preexposure prophylaxis.
Croatian: Zdravstveni radnici dobit će i brošuru te karticu s podsjetnikom namijenjenu osobama koje primaju lijek za predekspozicijsku profilaksu.
English: In addition, it may be used in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.
Croatian: Nadalje, može se primjenjivati u adolescenata koji su zaraženi HIV-om, a otporni su na lijekove prve linije ili ih ne mogu primati zbog nuspojava.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Krka are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Emtricitabine/Tenofovir disoproxil Krka pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka has been shown to have comparable quality and to be bioequivalent to Truvada.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da lijek Emtricitabine/Tenofovir disoproxil Krka posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Truvada.
English: If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Croatian: Ako bolesnici moraju prekinuti liječenje emtricitabinom ili tenofovirom, odnosno uzimati drugačije doze, moraju odvojeno uzimati lijekove koji sadrže emtricitabin ili tenofovirdizoproksil.
English: Further information on Emtricitabine/Tenofovir disoproxil Krka can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka.
Croatian: Više informacija o lijeku Emtricitabine/Tenofovir disoproxil Krka nalazi se na internetskim stranicama Agencije: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka Informacije o referentnom lijeku također se nalaze na internetskim stranicama Agencije.
English: Emtricitabine/Tenofovir disoproxil Krka does not cure HIV infection or AIDS, but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Emtricitabine/Tenofovir disoproxil Krka ne liječi infekciju HIV-om ni AIDS, no odgađa oštećenje imunosnog sustava i razvoj infekcija te bolesti povezanih s AIDS-om.
English: Because Emtricitabine/Tenofovir disoproxil Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Emtricitabine/Tenofovir disoproxil Krka generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Emtricitabine/Tenofovir disoproxil Krka is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Croatian: Lijek Emtricitabine/Tenofovir disoproxil Krka dostupan je u obliku tableta (200 mg emtricitabina i 245 mg tenofovirdizoproksila).
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Ispitivanja omjera koristi i rizika djelatnih tvari u odobrenoj primjeni već su provedena s referentnim lijekom Truvada i ne treba ih ponavljati za lijek Emtricitabine/Tenofovir disoproxil Krka.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Croatian: Emtricitabin i tenofovir djeluju na sličan način, onemogućujući djelovanje reverzne transkriptaze, enzima koji proizvodi HIV i koji virusu omogućuje reprodukciju u zaraženim stanicama.
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Croatian: Kada je riječ o predekspozicijskoj profilaksi infekcije virusom HIV-1, očekuje se da će Emtricitabine/Tenofovir disoproxil Krka u krvi zaustaviti razmnožavanje virusa i širenje s mjesta infekcije ako je osoba izložena virusu.
English: The company that markets Emtricitabine/Tenofovir disoproxil Krka will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka on kidney function, and information about use for pre-exposure prophylaxis.
Croatian: Tvrtka koja stavlja na tržište lijek Emtricitabine/Tenofovir disoproxil Krka osigurat će informativni paket za liječnike koji obuhvaća potencijalne štetne učinke lijeka Emtricitabine/Tenofovir disoproxil Krka na funkciju bubrega i informacije za primjenu u predekspozicijskoj profilaksi.
English: Emtricitabine/Tenofovir disoproxil Krka (emtricitabine / tenofovir disoproxil)
Croatian: Emtricitabine/Tenofovir disoproxil Krka (emtricitabin/tenofovirdizoproksil )
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Emtricitabine/Tenofovir disoproxil Krka također se nalaze u sažetku opisa svojstava i uputi o lijeku.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Emtricitabine/Tenofovir disoproxil Krka.
English: Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Croatian: Emtricitabine/Tenofovir disoproxil Krka koristi se i za sprečavanje spolno prenosive infekcije virusom HIV-1 u odraslih osoba i adolescenata kod kojih postoji velik rizik od infekcije („predekspozicijska profilaksa”).
English: For more information about using Emtricitabine/Tenofovir disoproxil Krka, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Emtricitabine/Tenofovir disoproxil Krka pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Emtricitabine/Tenofovir disoproxil Krka?
English: Emtricitabine/Tenofovir disoproxil Krka can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Emtricitabine/Tenofovir disoproxil Krka izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Emtricitabine/Tenofovir disoproxil Krka lijek je protiv HIV-a koji se primjenjuje u kombinaciji s najmanje još jednim lijekom protiv HIV-a za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Therefore, the Agency's view was that, as for Truvada, the benefit of Emtricitabine/Tenofovir disoproxil Krka outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Emtricitabine/Tenofovir disoproxil Krka, kao i od lijeka Truvada, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: An overview of Emtricitabine/Tenofovir disoproxil Krka and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Emtricitabine/Tenofovir disoproxil Krka i zašto je odobren u EU-u
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil.
Croatian: Emtricitabine/Tenofovir disoproxil Krka sadrži dvije djelatne tvari, emtricitabin i tenofovirdizoproksil.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Emtricitabine/Tenofovir disoproxil Krka kontinuirano se prate.
English: Other information about Emtricitabine/Tenofovir disoproxil Krka
Croatian: Ostale informacije o lijeku Emtricitabine/Tenofovir disoproxil Krka
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Croatian: Emtricitabine/Tenofovir disoproxil Krka sadrži dvije djelatne tvari: emtricitabin, nukleozidni inhibitor reverzne transkriptaze, i tenofovirdizoproksil, „prolijek” tenofovira.
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Krka?
Croatian: Koje su koristi i rizici od lijeka Emtricitabine/Tenofovir disoproxil Krka?
English: What is Emtricitabine/Tenofovir disoproxil Krka and what is it used for?
Croatian: Što je Emtricitabine/Tenofovir disoproxil Krka i za što se primjenjuje?
English: For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Krka, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s najmanje još jednim lijekom protiv HIV-a, Emtricitabine/Tenofovir disoproxil Krka smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: Why is Emtricitabine/Tenofovir disoproxil Krka authorised in the EU?
Croatian: Zašto je lijek Emtricitabine/Tenofovir disoproxil Krka odobren u EU-u?
English: How is Emtricitabine/Tenofovir disoproxil Krka used?
Croatian: Kako se koristi Emtricitabine/Tenofovir disoproxil Krka?
English: How has Emtricitabine/Tenofovir disoproxil Krka been studied?
Croatian: Kako je lijek Emtricitabine/Tenofovir disoproxil Krka ispitivan?
English: How does Emtricitabine/Tenofovir disoproxil Krka work?
Croatian: Kako djeluje Emtricitabine/Tenofovir disoproxil Krka?
English: 1 dose per year.
Croatian: 1 doza godišnje.
English: (* equivalent to titre prior to inactivation)
Croatian: (* jednako titru prije inaktivacije)
English: These measures should help protect the environment.
Croatian: Te mjere pomažu u zaštiti okoliša.
English: Date of first authorisation: 21/11/2017
Croatian: Datum prvog odobrenja: 21/11/2017
English: Milton Keynes, MK7 7AJ UK
Croatian: Milton Keynes, MK7 7AJ
English: Each ml of vaccine contains:
Croatian: Svaki ml cjepiva sadrži:
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i/ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EZ Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Croatian: *(Ciklička vrijednost (Ct) ≥ 36 prema validiranoj metodi RT-PCR, što ukazuje na odsutnost virusnog genoma).
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Croatian: Razina djelotvornosti kod drugih vrsta može se razlikovati od razine zabilježene kod ovaca i goveda.
English: Purified saponin (Quil A)
Croatian: Pročišćeni saponin (Quil A)
English: White or pinkish-white.
Croatian: Bijele ili ružičasto-bijele boje.
English: Walton Manor,
Croatian: Walton Manor, Walton,
English: Cattle from 2.5 months of age:
Croatian: Goveda od 2,5 mjeseci života:
English: Loss of appetite can occur in very rare cases.
Croatian: U vrlo rijetkim slučajevima može doći do gubitka apetita.
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Croatian: Ako se primjenjuje na drugim vrstama domaćih ili divljih preživača za koje se smatra da su ugrožene infekcijom, primjeni cjepiva kod takvih vrsta potrebno je pristupiti s oprezom te se savjetuje testirati cjepivo na malom broju životinja prije masovnog cijepljenja.
English: 0.1 mg For the full list of excipients, see section 6.1.
Croatian: 0,1 mg Potpuni popis pomoćnih tvari vidi u dijelu 6.1.
English: Duration of immunity: 1 year after the second dose.
Croatian: Trajanje imunosti: 1 godina nakon druge doze.
English: Avoid introduction of contamination.
Croatian: Izbjegavati kontaminaciju.
English: Sheep from 2.5 months of age:
Croatian: Ovce od 2,5 mjeseca života:
English: The NETHERLANDS
Croatian: NIZOZEMSKA
English: It lasted not longer than 24 to 48 hours.
Croatian: Povećana tjelesna temperatura traje od 24 do 48 sati.
English: Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Croatian: Svaki raspored cijepljenja treba odobriti nadležno tijelo ili odgovorni veterinar, uzimajući u obzir lokalnu epidemiološku situaciju.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi/kutiji.
English: Pregnancy: Can be used during pregnancy.
Croatian: Graviditet i laktacija: Može se primijeniti tijekom graviditeta.
English: La Relva s/n, 36400 Porriño
Croatian: 36400 Porriño
English: Avoid multiple vial broaching.
Croatian: Izbjegavati višestruko bušenje bočice.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i primjenjivati ovaj veterinarsko medicinski proizvod mora se prvo savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjene u državi članici,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Croatian: U ovoj kategoriji životinja cjepivo je potrebno primjenjivati samo u skladu s procjenom omjera koristi i rizika od strane odgovornog veterinara i/ili nacionalnog nadležnog tijela u pogledu važećih odredbi o cijepljenju protiv virusa plavog jezika (BTV, od engl. blue tongue virus).