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: - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 µg/ml was reached within 1 hour in pigs.
Croatian: Nakon jedne intramuskularne doze od 0,4 mg meloksikama/kg, vrijednost Cmax od 1,1 do 1,5 µg/ml dosegnuta je u svinja nakon 1 sata.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice samoinjicira, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: MANUFACTURER´S BATCH NUMBER
Croatian: BROJ PROIZVODNE SERIJE Serija {broj}
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Croatian: Nakon jedne supkutane doze od 0,5 mg meloksikama/kg, vrijednosti Cmaxod 2,1 µg/ml postignute su nakon 7,7 sati u mladih goveda, a od 2,7 µg/ml nakon 4 sata u krava u razdoblju laktacije.
English: Novem 40 mg/ml solution for injection for cattle
Croatian: Novem 40 mg/ml otopina za injekcije za goveda
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
English: Novem 5 mg/ml solution for injection for cattle and pigs
Croatian: Novem 5 mg/ml otopina za injekcije za goveda i svinje
English: Active substance: Meloxicam 5 mg
Croatian: Djelatna tvar: Meloksikam 5 mg
English: Cattle: SC injection.
Croatian: Goveda: s.c. injekcija Svinje: i.m. injekcija
English: Meloxicam 40 mg/ml
Croatian: Meloksikam 40 mg/ml
English: Equidae
Croatian: evidi
English: Cardboard box with either 1 or 6 colourless glass injection vial(s) of 250 ml.
Croatian: Kartonska kutija s 1 ili 6 bezbojnih staklenih injekcijskih bočica od 250 ml.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Croatian: Meloksikam ima također svojstva protiv endotoksičnosti, jer se pokazalo da koči proizvodnju tromboksana B2 potaknutog unosom endotoksina E. coli u teladi, krava tijekom laktacije i svinja.
English: Meloxicam 20 mg Ethanol
Croatian: Meloksikam 20 mg Etanol 150 mg
English: Vials, 20 ml and 50 ml
Croatian: Bočice, 20 ml i 50 ml
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and lactating cows.
Croatian: Meloksikam ima također svojstva protiv endotoksičnosti, jer se pokazalo da koči proizvodnju tromboksana B2 potaknutog unosom endotoksina E. coli u teladi i krava u razdoblju laktacije.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Croatian: 55216 Ingelheim/Rhein
English: Meat and offal: 15 days; milk: 5 days.
Croatian: Meso i jestive iznutrice: 15 dana; mlijeko: 5 dana.
English: Anti-inflammatory agents/Non-steroidal anti-inflammatory agents
Croatian: Protuupalna sredstva/nesteroidn a protuupalna sredstva
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Croatian: 14. RIJEČI "ČUVATI IZVAN POGLEDA
English: Vial, 100 ml
Croatian: Bočica, 100 ml
English: PACKAGE LEAFLET: Novem 40 mg/ml solution for injection for cattle
Croatian: UPUTA O VMP: Novem 40 mg/ml otopina za injekcije za goveda
English: TARGET SPECIES
Croatian: CILJNE VRSTE ŽIVOTINJA Goveda
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije u promet
English: Special precautions to be taken by the person administering the veterinary medicinal product Accidental self-injection may give rise to pain.
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: PACKAGE LEAFLET: Novem 20 mg/ml solution for injection for cattle and pigs
Croatian: UPUTA O VMP: Novem 20 mg/ml otopina za injekcije za goveda i svinje
English: A slight transient painless swelling at the injection site was observed in laboratory studies.
Croatian: U laboratorijskim ispitivanjima primijećena je blaga, privremena bezbolna oteklina na mjestu uboda.
English: EU/2/04/042/016 100 ml EU/2/04/042/018 12 x 100 ml
Croatian: EU/2/04/042/018 12 x 100 ml
English: Cattle: SC Pigs:
Croatian: PUT(EVI) PRIMJENE Goveda: s.c.
English: PACKAGE LEAFLET: Novem 5 mg/ml solution for injection for cattle and pigs
Croatian: UPUTA O VMP: Novem 5 mg/ml otopina za injekcije za goveda i svinje
English: Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Water for injection
Croatian: 6.1 Popis pomoćnih tvari etanol poloksamer 188 natrijev klorid glicin natrijev hidroksid glikofurol meglumin voda za injekcije
English: Pregnancy and lactation Can be used during pregnancy and lactation.
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Može se primijeniti tijekom graviditeta i laktacije.
English: Carton for 20 ml, 50 ml, 100 ml and 250 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija za 20 ml, 50 ml, 100 ml i 250 ml
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml were reached after 7.7 hours in young cattle.
Croatian: Nakon jedne supkutane doze od 0,5 mg meloksikama/kg, vrijednosti Cmax od 2,1 µg/ml postignute su nakon 7,7 sati u mladih goveda, a od 2,7 µg/ml nakon 4 sata u krava u razdoblju laktacije.
English: Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml.
Croatian: Kartonska kutija koja sadrži 1 ili 12 bezbojnih staklenih injekcijskih bočica od 20 ml, 50 ml ili 100 ml,
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Croatian: Svinje: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/100 kg tjelesne mase) u kombinaciji s terapijom antibioticima, po potrebi.
English: EU/2/04/042/001 1 x 100 ml EU/2/04/042/002 12 x 100 ml
Croatian: EU/2/04/042/002 12 x 100 ml
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Boehringer Ingelheim Vetmedica GmbH
English: 4.6 Adverse reactions (frequency and seriousness) A slight transient painless swelling at the injection site was observed in laboratory studies.
Croatian: U laboratorijskim ispitivanjima primijećena je blaga, privremena bezbolna oteklina na mjestu uboda
English: Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Croatian: Pakiranje od 1 ili 12 bezbojnih staklenih injekcijskih bočica, koje sadrže 50 ml ili 100 ml.
English: To obtain the best possible pain relieving effect post-surgery Novem should be administered 30 minutes before surgical intervention.
Croatian: Da bi se poslije operacije postigao najbolji učinak u olakšavanju bolova, Novem treba primijeniti
English: Manufacturer responsible for batch realease: Labiana Life Sciences S.A.
Croatian: Labiana Life Sciences S.A.
English: Vial, 50 ml
Croatian: Bočica, 50 ml
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: Accidental self-injection may give rise to pain.
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs:
Croatian: Goveda: Meso i jestive iznutrice: 15 dana; mlijeko: 5 dana Svinje: Meso i jestive iznutrice: 5 dana
English: Single subcutaneous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Jedna subkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 1,25 ml/100 kg tjelesne mase) u kombinaciji s antibiotskom terapijom ili peroralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Pack sizes of 1 or 12 colourless glass injection vial(s) of 50 ml or 100 ml.
Croatian: Pakiranje kapaciteta 1 ili 12 bezbojnih staklenih injekcijskih bočica od 50 ili 100 ml.
English: Novem 20 mg/ml solution for injection for cattle and pigs Meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Novem 20 mg/ml otopina za injekcije za goveda i svinje Meloksikam
English: Poloxamer 188 Sodium chloride Glycine
Croatian: Etanol poloksamer 188 makrogol 300 glicin dinatrijev edetat natrijev hidroksid klorovodična kiselina meglumin voda za injekcije
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
English: Novem 5 mg/ml solution for injection for cattle and pigs Meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Novem 5 mg/ml otopina za injekcije za goveda i svinje Meloksikam
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose, symptomatic treatment should be initiated.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti):
English: Novem 40 mg/ml solution for injection for cattle Meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Novem 40 mg/ml otopina za injekcije za goveda Meloksikam
English: Novem 40 mg/ml solution for injection for cattle meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Novem 40 mg/ml otopina za injekcije za goveda meloksikam
English: Once broached, use by...
Croatian: Jednom odčepljen upotrijebiti do…
English: Once broached, use by….
Croatian: Jednom otvorenu, upotrijebiti do….
English: EU/2/04/042/011 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014 6 x 250 ml
Croatian: EU/2/04/042/006 1x250 ml EU/2/04/042/011 12 x 20 ml EU/2/04/042/012 12 x 50 ml EU/2/04/042/013 12 x 100 ml EU/2/04/042/014 6 x 250 ml
English: One ml contains: Meloxicam 5 mg Ethanol
Croatian: Meloksikam 5 mg Etanol 150 mg
English: Active substance: Meloxicam 20 mg
Croatian: SASTAV DJELATNIH TVARI Meloksikam 20 mg/ml
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Croatian: Svinje: Može se primijeniti tijekom graviditeta i laktacije.
English: Overdose (symptoms, emergency procedures, antidotes) In case of overdose symptomatic treatment should be initiated.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti)
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Goveda: Jedna supkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 10,0 ml/100 kg tjelesne mase) u kombinaciji s terapijom antibioticima ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Goveda: Jedna supkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 2,5 ml/100 kg tjelesne mase) u kombinaciji s terapijom antibioticima ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Glycine
Croatian: KARENCIJA
English: Cardboard box with either 1 or 12 colourless glass injection vials each containing 20 ml, 50 ml or 100 ml.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Kartonska kutija koja sadrži 1 ili 12 bezbojnih staklenih injekcijskih bočica od 20 ml, 50 ml ili 100 ml.
English: Cattle: Meat and offal: 15 days Pigs:
Croatian: Goveda: meso i jestive iznutrice: 15 dana Svinje: meso i jestive iznutrice: 5 dana
English: MA (EU) Number
Croatian: MA (EU) Broj
English: (Invented) name
Croatian: (Smišljeno) ime
English: Intermittent spreading is possible as well.
Croatian: Također je moguće intermitentno širenje.
English: Date of last renewal: 30/08/2012
Croatian: Datum zadnje obnove: 30/08/2012
English: Other animals, such as rabbits and small rodents, have not been tested.
Croatian: Druge životinje, kao i zečevi i mali glodavci još nisu testirani.
English: After overdose, identical signs appear particularly in very young susceptible kittens.
Croatian: Nakon predoziranja, identični znakovi se pojavljuju osobito kod vrlo mladih i osjetljivih mačića.
English: Do not use after the expiry date which is stated on the label.
Croatian: Ne upotrebljavati nakon datuma isteka roka valjanosti navedenog na naljepnici.
English: Duration of immunity: The duration of immunity is up to 1 year.
Croatian: Trajanje imunosti: Imunitet traje 1 godinu.
English: Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Croatian: Rok valjanosti veterinarsko medicinskog proizvoda pakiranog za prodaju: 5 godina.
English: If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.
Croatian: Ako se upotrebljava bilo koji antibiotik u roku od tjedan dana nakon cijepljenja, cijepljenje treba ponoviti nakon završenog liječenja s antibiotikom.
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 their territory if it is established that:
Croatian: Sukladno članku 71 Direktive 2001/82/EC Europskog Parlamenta i Vijeća države članice zabranjuju ili mogu, u skladu s državnom legislativom zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskih proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da: a)
English: Sneezing by cats after administration does not adversely affect the efficacy of the veterinary medicinal product.
Croatian: Kihanje mačke nakon primjene ne utječe nepovoljno na djelotvornost veterinarsko medicinskog proizvoda.
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: Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs.
Croatian: Psi, svinje i necijepljene mačke mogu reagirati na vakcinalni soj s blagim i prolaznim respiratornim znakovima.
English: ADVICE ON CORRECT ADMINISTRATION
Croatian: SAVJJETI ZA ISPRAVNU PRIMJENU
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 Europske Medicinske Agencije http://www.emea.europa.eu/.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use for special warnings for immunocompromised humans.
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Prije upotrebe pročitati uputu o VMP i specijalna upozorenja za imunokompromirane ljude.
English: From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Croatian: U literaturi se navodi da ovaj tip intranazalnog cjepiva može izazvati imunološki odgovor, bez interferencije s materalnim antitijelima.
English: The duration of immunity is up to 1 year.
Croatian: Imunost traje 1 godinu.
English: To stimulate active immunity against Bordetella bronchiseptica.
Croatian: Za stimuliranje aktivnog imuniteta protiv Bordetella bronchiseptica.
English: For nasal use.
Croatian: Za nazalnu upotrebu.
English: Presentations:
Croatian: Prezentacije:
English: Shelf-life after reconstitution according to directions: 4 hours
Croatian: Rok valjanosti nakon rekonstitucije u skladu s uputama: 4 sata.
English: Shake well after addition of the solvent.
Croatian: Dobro protresti kada se doda otapalo.
English: Shake well.
Croatian: Dobro protresti..
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 0.5 ml
Croatian: 3. SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA 0,5 ml
English: 375 South Lake Street, Minnesota 56187, Worthington U.S.A.
Croatian: Minnesota 56187, Worthington
English: Shelf life after reconstitution: use within 4 hours.
Croatian: Rok valjanosti nakon Nakon rekonstitucije: upotrijebiti unutar 4 sata.
English: Such individuals should also be aware that cats can shed the organism for up to 1 year after vaccination.
Croatian: Takve osobe moraju biti svjesne da mačke mogu iz organizma izlučivati navedene mikroorganizme do godinu dana nakon cijepljenja.
English: The marketing authorisation holder must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Croatian: Nositelj odobrenja treba osigurati da je sustav farmakovigilancije, kako je opisano u Dijelu I zahtjeva za izdavanje odobrenja, uspostavljen i funkcionalan prije i za vrijeme stavljanja veterinarsko medicinskog proizvoda u promet.rijeme stavljanja veterinarsko medicinskog proizvoda u promet.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Odluka o upotreni ovog cjepiva prije ili nakon nekog drugog veterinarsko medicinskog proizvoda treba biti donesena od slučaja do slučaja.
English: 21960 Intervet Lane, Delaware 19966, Millsboro U.S.A.
Croatian: Delaware 19966, Millsboro
English: In cats that show more severe signs, appropriate antibiotic treatment may be indicated.
Croatian: Kod mačaka, koje pokazuju teže znakove, treba liječiti odgovarajućim antibiotikom.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose.
Croatian: 3. SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA 1 doza.
English: Only healthy cats should be vaccinated.
Croatian: Samo zdrave životinje mogu biti cijepljenje.
English: Place the syringe in front of one of the nostrils and carefully administer the whole contents of the syringe into the nasal cavity via this nostril.
Croatian: Staviti špricu ispred jedne od nosnica i pažljivo aplicirati cijeli sadržaj šprice u nosnu šupljinu te nosnice.
English: No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available.
Croatian: Nema dostupnih podataka o utjecaju majčinih protutijela na učinak cijepljenja sa Nobivac Bb za mačke.
English: The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is forced to breathe through its nostrils.
Croatian: Glava mačke, kao i nos, moraju biti okrenuti prema gore a usta zatvorena kako bi ju se prisililo da diše kroz nos.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
Croatian: I POGLEDA DJECE” Čuvati izvan dosega i pogleda djece.
English: Dispose of waste material that has had contact with the active substance by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Croatian: Odlagati otpadne materijale uranjanjem u kipuću vodu, spaljivati, uranjati u prikladno dezinfekcijsko sredstvo odobreno za upotrebu od strane nadležnog tijela.
English: Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat's nostrils.
Croatian: Povući 0,2 ml rekonstituiranog cjepiva u 1 ml ili 2 ml šprice, maknuti iglu i aplicirati cijeli sadržaj u jednu od nosnica mačke.
English: One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent sealed with a halogenobutyl rubber stopper.
Croatian: Jedna doza bočice od 3 ml liofilizata zatvorena je halogeno butil gumenim čepom i aluminijskim poklopcem, isporučena s bočicom od 0,5 ml sterilnog otapala zapečaćenog halogenbutil gumenim čepom.
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Croatian: Wim de Körverstraat 35 NL - 5831 AN Boxmeer Nizozemska
English: Solvent: Water for injection
Croatian: Otapalo: Voda za injekcije
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and 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: će primjena proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja. b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: 1. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: Do not administer during antibiotic treatment, or in conjunction with any other intranasal veterinary medicinal product.
Croatian: Ne primjenjivati tijekom liječenja s antibioticima ili zajedno sa bilo kojim intranazalnim veterinarsko medicinskim proizvodom.
English: The import, sale, supply and/or use of Nobivac Bb for cats is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Croatian: Uvoz, prodaja, opskrba i/ili primjena Nobivaca Bb je ili može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim odredbama zaštite zdravlja životinja.
English: Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
Croatian: Odgovarajući postupci dezinfekcije moraju se primijeniti prema uputama u postupanju s ovim živim bakterijskim cjepivom
English: Any person intending to import, sell, supply and/or use Nobivac Bb for cats must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Croatian: Tko namjerava uvesti, prodavati, opskrbljivati i/ili primjenjivati Nobivac Bb mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.
English: Pharmacovigilance system
Croatian: Sustav farmakovigilancije.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva s bilo kojim drugim veterinarsko medicinskim proizvodom.