FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated administration of VarroMed might be required for spring or autumn treatment at intervals of 6 days; repeated applications should only be performed as indicated by mite-fall in according with the following table:
Croatian: Za tretmane u proljeće ili jesen možda će biti potrebna ponovljena primjena u vremenskim razmacima od 6 dana, pri čemu ponavljane primjene treba provoditi samo prema padu grinja sukladno sljedećoj tablici: Sezona
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion Formic acid/oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA VarroMed 75 mg + 660 mg, disperzija za košnice Mravlja kiselina/dihidrat oksalne kiseline
English: PACKAGE SIZE 555 ml
Croatian: 555 ml
English: 44 mg (equivalent to 31.42 mg oxalic acid)
Croatian: 44 mg (istovjetno 31,42 mg oksalne kiseline)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion Formic acid/oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA VarroMed 5 mg/ml + 44 mg/ml, disperzija za košnice Mravlja kiselina/dihidrat oksalne kiseline
English: PHARMACEUTICAL FORM Bee-hive dispersion.
Croatian: OBLIK Disperzija za košnice.
English: Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
Croatian: Liječenje varooze (Varroa destructor) u kolonijama medonosnih pčela s leglom i bez legla.
English: Oxalic acid
Croatian: Oksalna kiselina
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Formic acid
Croatian: Djelatne tvari: Svaki ml sadrži: Mravlja kiselina
English: Honey: Zero days.
Croatian: grinje na dan.
English: No data are available which confirm this activity after trickling of 0.5% formic acid; however, formic acid in the fixed combination of VarroMed is considered to extend the duration of the effect of oxalic acid, and to improve the tolerance of the product.
Croatian: Nisu dostupni podaci koji potvrđuju tu aktivnost nakon kapanja 0,5 % mravlje kiseline.
English: 4.9 Amounts to be administered and administration route In-hive use.
Croatian: Količine koje se primjenjuju i put primjene Primjena u košnici.
English: Formic acid
Croatian: Mravlja kiselina
English: During the application of the veterinary medicinal product, wear protective clothing, acid-resistant gloves and glasses.
Croatian: Nosite zaštitnu odjeću, rukavice otporne na kiseline i zaštitne naočale tijekom primjene ovog veterinarsko-medicinskog proizvoda.
English: PHARMACEUTICAL FORM Bee-hive dispersion
Croatian: OBLIK Disperzija za košnice
English: up to 5x possible in late summer/early autumn with decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Croatian: Tretman je potrebno što prije provesti u kasno ljeto/ranu jesen kada se smanjuje populacija kolonije i kada je prirodni pad grinja veći od 4 grinje na dan.
English: None known.
Croatian: NEMA UNOSA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
Croatian: VarroMed 5 mg/ml + 44 mg/ml, disperzija za košnice za medonosne pčele
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees
Croatian: VarroMed 75 mg + 660 mg, disperzija za košnice za medonosne pčele
English: WITHDRAWAL PERIOD(S) Honey: Zero days.
Croatian: KARENCIJA(E) Med: nula dana.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČAVANJE I UPUTA O VMP-u
English: decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Croatian: 5x jesen kada se smanjuje populacija kolonije i kada je prirodni pad grinja veći od 4
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/16/203/002
English: Spring
Croatian: NUSPOJAVE
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: smjesta upotrijebiti.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/16/203/001
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 15 ml Sachet
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Dose:
Croatian: Inkompatibilnosti:
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): Honey: Zero days.
Croatian: KARENCIJA(E) Karencija(e): med: nula dana.
English: The treatment should be repeated twice, 6 days apart (i.e. 3
Croatian: Tretman je potrebno dvaput ponoviti u razmaku od 6 dana
English: administrations).
Croatian: NJEMAČKA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02/02/2017
Croatian: Datum prvog odobrenja: 02/02/2017
English: Frequency of treatment:
Croatian: Učestalost tretmana:
English: TARGET SPECIES Honey bees.
Croatian: Medonosne pčele.
English: N/A Bees
Croatian: Pčele
English: WITHDRAWAL PERIOD(S) Withdrawal period(s) (honey): zero days.
Croatian: KARENCIJA(E) Karencija(e) (med): nula dana.
English: BeeVital GmbH Wiesenbergstr.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET BeeVital GmbH
English: STATEMENT OF ACTIVE SUBSTANCES Active substances:
Croatian: SASTAV DJELATNIH TVARI Djelatne tvari:
English: No of applications
Croatian: Broj primjena
English: ROUTE(S) OF ADMINISTRATION In-hive use.
Croatian: PUT(EVI) PRIMJENE Primjena u košnici.
English: In very rare cases (<1/100,000), hypersensitivity can be observed.
Croatian: U vrlo rijetkim slučajevima (< 1/100 000) može se pojaviti preosjetljivost.
English: Wash and disinfect hands and equipment after use.
Croatian: Oprati i dezinficirati ruke i opremu nakon primjene.
English: One dose of 2 ml contains:
Croatian: Jedna doza od 2 ml sadrži:
English: Mineral oil (Marcol 52)
Croatian: Mineralno ulje (Marcol 52)
English: Do not mix with any other vaccine or immunological product.
Croatian: Ne miješati s bilo kojim drugim cjepivom ili imunološkim proizvodom.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.>
English: Use sterile syringes and needles.
Croatian: Upotrebljavajte sterilne štrcaljke i igle.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 10 doses
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Osim povećanja opsega reakcije tkiva na mjestu injiciranja, nisu uočene nikakve druge nuspojave.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici European Medicines Agency http://www.ema.europa.eu/.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“ I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: A second dose may be injected 3-4 weeks after the first injection.
Croatian: Druga doza može se injicirati 3 - 4 tjedna nakon prve injekcije.
English: Zoetis B.V., Podružnica Zagreb za promidžbu
Croatian: Hrvatska Zoetis B.V., Podružnica Zagreb za promidžbu
English: Each piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
Croatian: Svaki praščić cijepljenih nazimica ili krmača trebao bi unijeti dovoljnu količinu kolostruma i mlijeka.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Powder:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Prašak:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko medicinski proizvod na životinjama
English: Mannide mono oleate (Arlacel A)
Croatian: Manid monooleat (Arlacel A)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/08/1998
Croatian: Datum prvog odobrenja: 07/08/1998 Datum posljednjeg produljenja odobrenja: 22/08/2008
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije roka valjanosti naznačenog na etiketi poslije EXP.
English: • Inject one dose per gilt before the first mating, or
Croatian: • Injicirati jednu dozu po nazimici prije prvog parenja ili
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/EK i 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: Polysorbate 80 (Tween 80)
Croatian: Polisorbat 80 (Tween 80)
English: Shelf-life after reconstitution according to directions: 1 hour.
Croatian: Rok valjanosti nakon rekonstitucije prema uputama: 1 sat.
English: • Inject one dose per gilt or sow during each gestation at 3-6 weeks before the expected date of farrowing.
Croatian: • Injicirati jednu dozu po nazimici ili krmači tijekom svake gestacije 3 - 6 tjedana prije očekivanog datuma prasenja.
English: • Inject one dose per boar at least every 6 months.
Croatian: • Injicirati jednu dozu po nerastu barem svakih 6 mjeseci.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton label 1 x 10 doses, 1 x 50 doses, 1 x 100 doses, 10 x 10 doses, 10 x 50 doses, 10 x 100 doses
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Etiketa na kutiji 1 x 10 doza, 1 x 50 doza, 1 x 100 doza, 10 x 10 doza, 10 x 50 doza, 10 x 100 doza
English: Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Croatian: Osim povećanja opsega reakcije tkiva na mjestu injiciranja, nisu uočene nikakve druge nuspojave.
English: Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
Croatian: Primijenite intramuskularnom injekcijom 1 doze (2 ml) po svinji u vrat u području iza uha.
English: For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Croatian: Za cijepljenje čitavog stada treba primijeniti injekciju od jedne doze po svakoj nazimici, krmači i nerastu svaka 4 mjeseca.
English: The presence of maternal antibodies against Aujeszky's disease virus may have a negative influence on the result of vaccination.
Croatian: Prisutnost majčinih protutijela protiv virusa bolesti Aujeszkoga može imati negativan utjecaj na rezultat cijepljenja.
English: * CCID50 - the quantity of virus, which infects 50 % of the cell cultures inoculated.
Croatian: * CCID50 = količina virusa, koja inficira 50% inokuliranih staničnih kultura.
English: Therefore, the product is suitable to be used in eradication programmes against Aujeszky's disease field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
Croatian: Stoga je proizvod pogodan za primjenu u programima iskorjenjivanja terenskog virusa bolesti Aujeszkoga kod svinja na temelju prisutnosti ili odsutnosti protutijela protiv gE-antigena tog virusa.
English: Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50 % of the pigs.
Croatian: Blage, prolazne i lokalne reakcije do 2 cm u promjeru nakon prvog cijepljenja i do 5 cm nakon drugog cijepljenja mogu se pojaviti u do 50% svinja.
English: Vaccination programme:
Croatian: Program cijepljenja:
English: A transient increase in body temperature, up to about 40,5 oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
Croatian: Prolazno povišenje tjelesne temperature, do približno 40,5°C u trajanju do 2 dana, može se pojaviti u malog broja svinja nakon cijepljenja.
English: Camprodón s/n "la Riba" 17813 Vall de Bianya
Croatian: Camprodón s/n "la Riba" 17813 Vall de Bianya Girona
English: The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Croatian: Bočice su zatvorene čepom od butilne gume i zapečaćene aluminijskom kapicom.
English: To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Croatian: Da biste rekonstituirali cjepivo, ubrizgajte 3 ml otapala u malu bočicu s praškom.
English: Any person intending to manufacture, import, possess, sell, supply and use Suvaxyn Aujeszky 783 + O/W 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.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati Suvaxyn Aujeszky 783 + O/W mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: Shelf life after reconstitution: Use within one hour.
Croatian: EXP {mjesec/godina} Rok valjanosti poslije rekonstitucije: potrošiti u roku od sat vremena
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Croatian: Zbrinite otpadni materijal prokuhavanjem, spaljivanjem ili uranjanjem u prikladno dezinfekcijsko sredstvo koje je nadležno tijelo odobrilo za upotrebu.
English: The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky's disease virus, if the vaccine is used in association with an appropriate diagnostic test.
Croatian: Karakteristika virusa cjepiva gE- (glikoprotein E negativni) omogućuje razlikovanje protutijela induciranih cijepljenjem ovim proizvodom i protutijela induciranih terenskom infekcijom virusom bolesti Aujeszkoga ako se cjepivo primjenjuje uz odgovarajući dijagnostički test.
English: Shelf-life of the veterinary medicinal product as packaged for sale (powder): 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju (prašak): 2 godine.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Croatian: 11. POSEBNE MJERE PRI ČUVANJU Čuvati izvan pogleda i dosega djece.
English: Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
Croatian: Temeljno cijepljenje tovnih svinja i rasplodnih svinja (nazimica, krmača i nerasta):
English: • Inject one dose per fattening pig from the age of 10 weeks.
Croatian: • Injicirati jednu dozu po tovnoj svinji od 10 tjedana starosti nadalje.
English: One dose (2 ml) of reconstituted emulsion containing ≥ 105.2 CCID50 of live attenuated Aujeszky's disease virus strain NIA3-783 for each pig.
Croatian: Jedna doza (2 ml) rekonstituirane emulzije koja sadrži ≥ 105,2 CCID50 živog, atenuiranog virusa bolesti Aujeszkoga soja NIA3-783 za svaku svinju.
English: Re-vaccination of breeding pigs (gilts, sows and boars):
Croatian: Revakcinacija rasplodnih svinja (nazimica, krmača i nerasta):
English: - Active immunity: The onset of immunity is from 3 weeks after basic vaccination.
Croatian: - Aktivni imunitet: Imunitet se javlja od trećeg tjedna nakon primarnog cijepljenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/009/001-006
Croatian: EU/2/98/009/001-006
English: The immunity lasts for 3 months after basic vaccination.
Croatian: Imunitet traje tri mjeseca nakon primarnog cijepljenja.
English: Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
Croatian: Potomci cijepljenih nazimica i krmača stječu pasivan imunitet putem kolostruma i mlijeka.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 ºC - 8 ºC).
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom (2 ºC - 8 ºC).
English: QUANTITY
Croatian: KOLIČINA
English: Pharmacotherapeutic group: live Aujeszky's disease vaccine.
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: Živa vakcina bolesti Aujeszkoga
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATIH TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE U PROMET
English: Accidental injection is dangerous - see package insert before use for further information and additional warnings.
Croatian: POSEBNA UPOZORENJA, AKO JE POTREBNO Nehotično je injiciranje opasno - vidi uputu o VMP prije primjene za daljnje informacije i dodatna upozorenja.
English: Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal
Croatian: Mineralno ulje (Marcol 52) Manid monooleat (Arlacel A) Polisorbat 80 (Tween 80) Tiomersal
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTOVI PRIMJENE
English: By reconstitution of the immunogen in the oil emulsion, the stimulation of immunity after injection is prolonged.
Croatian: Rekonstitucijom imunogena u uljnoj emulziji produljuje se stimulacija imuniteta nakon injekcije.
English: Shelf-life of the veterinary medicinal product as packaged for sale (solvent): 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju (otapalo): 2 godine.
English: In general these reactions disappear within 3 weeks after the first vaccination.
Croatian: Općenito, te se reakcije povlače unutar 3 tjedna nakon prvog cijepljenja.
English: • Inject one dose per breeding pigs (gilts, sows and boars) from the age of 10 weeks followed by a second injection 3-4 weeks after the first injection.
Croatian: • Injicirati jednu dozu po rasplodnoj svinji (nazimice, krmače i nerasti) od 10 tjedana starosti nadalje, a 3 - 4 tjedna kasnije treba primijeniti drugu injekciju.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Aujeszky's disease virus
Croatian: KOLIČINA DJELATNE(IH) TVARI Živi, atenuirani virus bolesti Aujeszkoga
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dosega djece.
English: The active substance stimulates active immunity against Aujeszky's disease in pigs.
Croatian: Djelatna tvar stimulira aktivni imunitet protiv bolesti Aujeszkoga kod svinja.
English: Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal.
Croatian: Aluminijev hidroksid, mineralno ulje (Marcol 52), manid monooleat (Arlacel A), polisorbat 80
English: To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Croatian: Da se tekućina ne bi zapjenila, nakon rekonstitucije liofilizirane komponente u tekućoj komponenti bočicu tresite nježno.
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Croatian: Zoetis Belgium SA Rue Laid Burniat 1
English: In general these reactions disappear within 3 weeks post primary vaccination.
Croatian: Općenito, te se reakcije povlače unutar 3 tjedna nakon primarnog cijepljenja.
English: Name and address of the manufacturers of the biological active substances Zoetis Manufacturing & Research Spain, S.L.
Croatian: Naziv i adresa proizvođača biološki djelatnih tvari Zoetis Manufacturing & Research Spain, S.L.
English: MANUFACTURER'S BATCH NUMBER Lot: {number} for the powder:
Croatian: Serija: {broj} za prašak: Serija: {broj} za otapalo:
English: Solvent for emulsion for injection:
Croatian: Otapalo za emulziju za injekciju:
English: Water for injections
Croatian: Manitol Voda za injekcije
English: Cardboard box with 1 vial of powder and 1 bottle of solvent or 10 vials of powder and 10 bottles of solvent for injection.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija s 1 bočicom praška i 1 bočicom otapala ili 10 bočica praška i 10 bočica otapala za injekciju.
English: INDICATION(S) Active and passive immunisation of pigs against Aujeszky's disease.
Croatian: Aktivna i pasivna imunizacija svinja protiv bolesti Aujeszkoga.
English: SPECIAL WARNING(S) Accidental injection is dangerous - see package insert before use.
Croatian: Nehotično je injiciranje opasno - vidi uputu o VMP prije primjene.
English: Name and address of the manufacturers responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije u promet Zoetis Manufacturing & Research Spain, S.L.
English: Excipient: Thiomersal
Croatian: Tiomersal
English: Live attenuated Aujeszky's disease virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion.
Croatian: Živi, atenuirani virus bolesti Aujeszkoga, soj NIA3-783: ≥ 105,2 CCID50* po dozi od 2 ml rekonstituirane emulzije.
English: Shake gently to dissolve the vaccine and transfer the dissolved vaccine into the vial with the solvent.
Croatian: Nježno protresite da bi se cjepivo rastopilo i premjestite rastopljeno cjepivo u bočicu s otapalom.
English: Powder for emulsion for injection:
Croatian: Prašak za emulziju za injekciju:
English: Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol
Croatian: Dinatrij-hidrogen-fosfat
English: WITHDRAWAL PERIOD Zero days.
Croatian: Karencija: Nula dana.
English: Active substance
Croatian: Djelatne tvari
English: ANNEX III LABELLING AND PACKAGE INSERT
Croatian: OZNAČAVANJE I UPUTA O VMP
English: 7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder.
Croatian: I koje sadrže 10, 50 ili 100 doza liofiliziranog praška.
English: Disposal: read package leaflet.
Croatian: Odlaganje: pročitati uputu o VMP
English: Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Croatian: Aktivna imunizacija svinja od 10 tjedana starosti nadalje radi sprječavanja smrtnosti i kliničkih znakova bolesti Aujeszkoga i reduciranja lučenja terenskog virusa bolesti Aujeszkyoga.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER SUBSTANCE(S)
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: 20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50doses or 100-doses presentation or Type II glass rinsed with WFI containing solvent for the 50-doses and 100-doses presentation.
Croatian: 20 ml, 100 ml ili 200 ml bočice od hidrolitičkog stakla tipa
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use of 1 dose (2 ml) per pig.
Croatian: Za intramuskularnu primjenu 1 doze (2 ml) po svinji
English: Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Croatian: Pasivna imunizacija potomstva cijepljenih nazimica i krmača radi reduciranja smrtnosti i kliničkih znakova bolesti Aujeszkoga i reduciranja lučenja terenskog virusa bolesti Aujeszkyoga.