FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Pomožne snovi (tudi dodatki), navedene v poglavju 6.1 SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
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, prohibitthe 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:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami država članica lahko v skladu z nacionalno zakonodajo prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
English: White homogeneous emulsion.
Slovenian: Bela homogena emulzija
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v tem navodilu za uporabo, obvestite svojega veterinarja.
English: Excipients: For the full list of excipients see section 6.1.
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: INDICATION
Slovenian: INDIKACIJA
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Slovenian: Stekleničke so zaprte z zamaški iz nitrilne gume in zatesnjene z aluminijasto zaporko s šifro.
English: Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Slovenian: Protitelesa so v serumu predvidoma prisotna najmanj 12 mesecev po dajanju dveh odmerkov cepiva.
English: This vaccine has been tested for safety in chickens.
Slovenian: Varnost cepiva je testirana pri piščancih.
English: Allow the vaccine to reach a temperature of 15 °C - 25 °C.
Slovenian: Cepivo naj doseže temperaturo 15 °C - 25 °C.
English: Special warnings for each target species
Slovenian: Posebna opozorila za vsako ciljno vrsto
English: Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Slovenian: Zmanjšanje kliničnih znakov, smrtnost in izločanje virusa po provokaciji se je dokazalo do tri tedne po cepljenju.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Nobilis Influenza H5N2 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Nobilis Influenza H5N2, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Slovenian: Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom.
English: Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Slovenian: Imunizacijo potomcev cepljenih živali je zato treba odložiti, dokler se količina protiteles ne zmanjša.
English: Shake well before use.
Slovenian: Pred uporabo ga dobro pretresite.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št. 470/2009.
English: Pharmacotherapeutic group: Immunologicals for Aves; Inactivated viral vaccines, avian influenza virus.
Slovenian: Farmakoterapevtska skupina: imunološka zdravila za perutnino; inaktivirana virusna cepiva, virus aviarne influence.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: The level of efficacy for other species may differ from that observed in chickens.
Slovenian: Učinkovitost pri drugih vrstah perutnine se lahko razlikuje od učinkovitosti pri piščancih.
English: A transient diffuse swelling may very commonly occur at the vaccination site, which persists for about 14 days.
Slovenian: Na mestu vboda lahko zelo pogosto nastane prehodna, difuzna oteklina, ki traja približno 14 dni.
English: The manufacture, import, possession, sale, supply and/or use of Nobilis Influenza H5N2 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba cepiva Nobilis Influenza H5N2 je lahko prepovedana v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: 3732 CN De Bilt
Slovenian: Ambachtstratt 4 3732 CN De Bilt
English: Chickens.
Slovenian: Piščanci.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pri več kot 1 toda manj kot 10 živalih od 100 živali) - občasni (pri več kot 1 toda manj kot 10 živalih od 1000 živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
English: The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Slovenian: Raven učinkovitosti se lahko razlikuje glede na stopnjo antigenske homologije med cepnim sevom in sevi na terenu.
English: Date of last renewal: 23/08/2011
Slovenian: Datum pridobitve dovoljenja za promet: 01.09.2006 Datum zadnjega podaljšanja: 23.08.2011
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach a temperature of 15 °C - 25 °C.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo naj doseže temperaturo 15 °C - 25 °C.
English: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Slovenian: Inaktivirani antigen podtipa virusa aviarne influence H5N2 (sev A/raca/Potsdam/1402/86), ki vzbudi titer HI ≥ 6,0 log2 pri preizkusu potentnosti.
English: If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Slovenian: Če ima divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivu, lahko cepljene živali razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
English: No information is available on vaccination in the presence of maternally derived antibodies.
Slovenian: Ni podatkov o cepljenju v prisotnosti maternalnihh protiteles.
English: Following the administration of a double dose, no adverse reactions other than those described in section 4.6 have been observed.
Slovenian: Po vnosu dvojnega odmerka niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 4.6. 4.11 Karenca
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Slovenian: Čeprav je bila injicirana le majhna količina, lahko nenamerno injiciranje tega zdravila povzroči močno oteklino, ki lahko na primer privede do ishemične nekroze ter celo do izgube prsta.
English: SPECIAL STORAGE PRECAUTIONS
Slovenian: Posebna navodila za shranjevanje
English: Shelf-life of the veterinary medicinal product as packaged for sale: PET vials: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: Viale iz PET: 2 leti
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control 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.
Slovenian: a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali b) bolezen, za katero se z zdravilom pridobi imunost, na območju skoraj ni prisotna.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku .
English: Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti in učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: For subcutaneous or intramuscular use.
Slovenian: Za subkutano ali intramuskularno uporabo.
English: Shelf life after first opening the container: 8 hours.
Slovenian: Rok uporabnosti po prvem odprtju vsebnika: 8 ur.
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
English: Adjuvant:
Slovenian: Dodatek:
English: Intervet International BV, site De Bilt Ambachtstraat 4
Slovenian: Intervet International IBV, site De Bilt
English: To the physician:
Slovenian: Namenjeno zdravniku:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use (0.25 to 0.5 ml, depending on the age).
Slovenian: Intramuskularna ali subkutana uporaba (0,25 do 0,5 ml, odvisno od starosti).
English: Store and transport refrigerated (2°C to 8°C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C do 8 °C).
English: If used in other avian 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 birds prior to mass vaccination.
Slovenian: Če ga uporabljamo pri drugih vrstah perutnine, za katere menimo, da pri njih obstoja tveganje okužbe, ga moramo uporabljati previdno, pred množičnim cepljenjem pa ga je priporočljivo preskusiti na majhnem številu živali.
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Slovenian: Nenamerno injiciranje/samo-injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
English: Name and address of the manufacturer responsible for batch release Intervet International BV
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Intervet International BV
English: Future laying hens and breeders: administer a second 0.5 ml dose 4-6 weeks after the first vaccination.
Slovenian: Bodoče nesnice in matične jate: dajte drugi odmerek 0,5 ml 4 do 6 tednov po prvem cepljenju.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Slovenian: Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
English: CONTRAINDICATIONS Do not administer intramuscularly in chickens less than 2 weeks old.
Slovenian: KONTRAINDIKACIJE Cepiva ne dajemo intramuskularno piščancem, mlajšim od 2 tednov.
English: Zero days.
Slovenian: Nič dni
English: PHARMACEUTICAL FORM Emulsion for injection
Slovenian: Emulzija za injiciranje
English: Incompatibilities Do not mix with any other veterinary medicinal product.
Slovenian: Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Do not administer intramuscularly in chickens less than 2 weeks old.
Slovenian: Cepiva ne dajemo intramuskularno piščancem, mlajšim od 2 tednov.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: TARGET SPECIES Chickens.
Slovenian: CILJNE ŽIVALSKE VRSTE Piščanci.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Slovenian: Zdravilo ne sme zmrzniti Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
English: 37008 Carbajosa de la Sagrada Salamanca
Slovenian: C/Zeppelin 6, Parcela 38 37008 Carbajosa de la Sagrada
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: The vaccine stimulates active immunity against avian influenza virus type A, subtype H5.
Slovenian: Cepivo vzbudi aktivno imunost proti virusu aviarne influence tipa A, podtip H5.
English: MARKETING AUTHORISATION HOLDER
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET
English: Active substance:
Slovenian: Zdravilna učinkovina:
English: THE WORDS “KEEP OUT OF THE SIGHTAND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec, odgovoren za sprostitev serije Intervet International B.V.
English: TARGET SPECIES Chickens
Slovenian: CILJNE ŽIVALSKE VRSTE Piščanci
English: For active immunisation of chickens against avian influenza type A, subtype H5.
Slovenian: Aktivna imunizacija piščancev proti aviarni influenci tipa A, podtip H5.
English: Shelf life after first opening the immediate packaging: use within 8 hours.
Slovenian: Rok uporabnost po prvem odprtju stične ovojnine: uporabite v 8 urah.
English: The safety of the veterinary medicinal product has not been established during lay.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini v obdobju nesnosti ni bila ugotovljena.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Spain
Slovenian: Salamanca Španija
English: Liquid light paraffin Polysorbate 80
Slovenian: Seznam pomožnih snovi tekoči lahki parafin polisorbat 80 sorbitan monooleat glicin
English: Veterinary medicinal product subject to prescription.
Slovenian: Na veterinarski recept.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Slovenian: Wim de Korverstraat 35 5831 AN Boxmeer
English: Lay The safety of the veterinary medicinal product has not been established during lay.
Slovenian: Nesnost Varnost zdravila za uporabo v veterinarski medicini ni bila ugotovljena med obdobjem nesnosti.
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly.
Slovenian: Od 14 dni do 6 tednov starosti: 0,25 ali 0,5 ml subkutano ali intramuskularno.
English: From 8 - 14 days old: 0.25 ml subcutaneously.
Slovenian: Od 8-14 dni starosti: 0,25 ml subkutano.
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only.
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Slovenian: Nenamerno samoinjiciranje je nevarno.
English: Poligono Industrial El Montalvo I C/Zeppelin 6, Parcela 38
Slovenian: Poligono Industrial Montalvo I
English: BATCH NUMBER Lot {number}
Slovenian: Serija{številka}
English: Cardboard box with 250 or 500 ml multidose PET bottle.
Slovenian: Kartonska škatla z večodmerno stekleničko po 250 ali 500 ml. Kartonska škatla z večodmerno plastenko iz PET po 250 ali 500 ml.
English: EXP {month/year} Once broached, use within 8 hours.
Slovenian: Načeto zdravilo uporabite v 8 urah.
English: 6 weeks and older: administer 0.5 ml subcutaneously or intramuscularly.
Slovenian: 6 tednov in starejši: dajte 0,5 ml subkutano ali intramuskularno.
English: Nobilis Influenza H5N2 emulsion for injection for chickens
Slovenian: Nobilis Influenza H5N2 emulzija za injiciranje za piščance
English: Special precautions for use in animals
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Liquid light paraffin: 234.8 mg.
Slovenian: Dodatek lahek tekoči parafin: 234,8 mg
English: Liquid light paraffin 234.8 mg
Slovenian: Tekoči lahki parafin, 234,8 mg
English: Adjuvant:Liquid light paraffin 234.8 mg
Slovenian: Dodatek: Tekoči lahki parafin, 234,8 mg
English: From 8 - 14 days old: administer 0.25 ml subcutaneously.
Slovenian: Od 8-14 dni starosti: dajte 0,25 ml subkutano.
English: 4.5 Special precautions for use
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion of injection for chickens.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H5N2, emulzija za injiciranje za piščance.
English: ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use.
Slovenian: Intramuskularna ali subkutana uporaba.
English: Cardboard box with 250 or 500 ml hydrolytical type II glass or polyethylene terephthalate (PET) bottles.
Slovenian: hidrolitične skupine ali iz polietilen tereftalata (PET).
English: PACKAGE LEAFLET FOR
Slovenian: VELIKOST PAKIRANJA
English: PACKAGE SIZE 250 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA 250 ml 500 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion for injection
Slovenian: Nobilis Influenza H5N2 emulzija za injiciranje
English: 4.8 Interactions with other medicinal products and other forms of interaction
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN
English: at least 17 weeks.
Slovenian: najmanj 17 tednov
English: 2 weeks post vaccination
Slovenian: 2 tedna po cepljenju
English: SPECIAL WARNINGS, IF NECESSARY
Slovenian: POSEBNA OPOZORILA, ČE JE/SO POTREBNA
English: • Vaccinate only pigs as from 3 weeks of age.
Slovenian: • Cepite samo prašiče, starejše od 3 tednov.
English: Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.
Slovenian: Sterilne igle za prenos (s certifikatom CE) so navadno na voljo pri dobaviteljih medicinske opreme.
English: Store and transport refrigerated (2 °C-8 °C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.
Slovenian: V zelo redkih primerih se lahko pojavijo anafilaktične reakcije in zdraviti jih je treba simptomatsko.
English: Use the entire vaccine mixture immediately after mixing.
Slovenian: Uporabite celotno mešanico cepiv takoj po zmešanju.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki nisu navedeni v tem navodilu za uporabo ali mislite da zadravilo ni delovalo, obvestite svojega veterinarja.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control 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.
Slovenian: a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
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.
Slovenian: Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo , se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.