natgillin/translations-raw huggingface dataset:
Treatment should be repeated every twelve weeks for optimal flea control.
Terapiju je potrebno ponoviti svakih dvanaest tjedana kako bi se postigla optimalna kontrola protiv buha.
The pipette to use is selected on the basis of the dog or cat's weight.
Odabir pipete koja se primjenjuje ovisi o težini psa ili mačke.
The most common side effect of the spot-on solution (which may affect more than 1 in 100 animals) is a mild short-lived skin reaction at the application site, such as erythema (redness) and pruritus (itching) or hair loss.
Najčešća je nuspojava otopine za nakapavanje (može se javiti u više od 1 na 100 životinja) blaga kratkotrajna kožna reakcija na mjestu primjene, poput eritema (crvenilo) i pruritusa (svrbež) ili gubitka dlake.
After being given, its actions last for 12 weeks against fleas and 8 to 12 weeks against ticks.
Nakon što se primijeni, Bravecto djeluje 12 tjedana protiv buha i 8 do 12 tjedana protiv krpelja.
In an EU field study involving 561 dogs with flea and/or tick infestations, the effects of Bravecto tablets were compared with those of another product, fipronil, that kills fleas and ticks, applied as a spot-on solution to the skin of the dogs.
U terenskom ispitivanju provedenom u EU-u na 561 psu s infestacijama buhama i/ili krpeljima djelovanje tableta Bravecto uspoređeno je s djelovanjem drugog proizvoda, fipronila, koji ubija buhe i krpelje i koji se primjenjuje kao otopina za nakapavanje na kožu pasa.
Bravecto and the comparator medicine were both 100% effective as all treated dogs were free from live mites when skin scrapings were taken on days 56 and 84 after treatment.
Bravecto i usporedni VMP bili su 100 % učinkoviti jer nijedan od liječenih pasa nije imao žive grinje 56. i 84. dana nakon liječenja kad su im uzeti uzorci kože.
Effectiveness was 95% and 94% for Bravecto chewable tablets and Bravecto spot-on solution respectively based on the percentage of dogs free from live mites at days 56 and 84 after treatment.
Učinkovitost je bila 95 % za tablete za žvakanje Bravecto te 94 % za otopinu za nakapavanje Bravecto, na temelju postotka pasa bez živih grinja 56. i 84. dana nakon primjene VMP-a.
• to treat ear mite infestations in cats.
• za liječenje infestacije ušnim šugarcem u mačaka.
For more information about using Bravecto, see the package leaflet or contact your veterinarian or pharmacist.
Za dodatne informacije o primjeni VMP-a Bravecto pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
The content of one full Bravecto pipette is applied to the dog or cat's skin between the shoulder blades of the dog and at the base of the skull of the cat.
Sadržaj jedne pipete u potpunosti napunjene VMP-om Bravecto primjenjuje se na kožu psa ili mačke, između lopatica psa te na bazu lubanje mačke.
After being given, its actions last for 12 weeks against fleas and ticks.
Nakon što se primijeni, Bravecto djeluje 12 tjedana protiv buha i krpelja.
What benefits of Bravecto have been shown in studies?
Koje su koristi VMP-a Bravecto utvrđene u ispitivanjima?
Treatment should be repeated every 12 weeks for optimal flea and tick control.
Terapiju je potrebno ponoviti svakih 12 tjedana kako bi se postigla optimalna kontrola protiv buha i krpelja.
A single treatment is required for demodectic and sarcoptic mange in dogs and ear mites in cats.
Potrebna je jedna terapija za liječenje demodikoze i sarkoptoze u pasa te infestacije ušnim šugarcima u mačaka.
The field study showed that Bravecto was effective in reducing the number of fleas and ticks in dogs with existing flea or tick infestations and that its effects against fleas and most tick species persisted for 3 months.
Terenskim je ispitivanjem utvrđeno da VMP Bravecto učinkovito u smanjuje broj buha i krpelja u pasa s postojećim infestacijama buhama ili krpeljima te da je njegovo djelovanje protiv buha i većine vrsta krpelja trajalo tijekom tri mjeseca.
Bravecto is available as a spot-on solution in a pipette for use on dogs and cats and as chewable tablets for use in dogs.
VMP Bravecto dostupan je u obliku otopine za nakapavanje u pipeti za primjenu u pasa i mačaka te u obliku tableta za žvakanje za primjenu u pasa.
Two further EU field studies involved dogs and cats with flea and/or tick infestations and compared the effects of Bravecto spot-on solution with fipronil spot-on solution.
U dva dodatna terenska ispitivanja provedena u EU-u na psima i mačkama s infestacijama buhama i/ili krpeljima uspoređeno je djelovanje otopine Bravecto za nakapavanje s djelovanjem otopine za nakapavanje fipronila.
Bravecto tablets are given around the dog's feeding time as a tablet of the appropriate strength for the dog's bodyweight.
Tablete se daju u vrijeme hranjenja psa, pri čemu jačina tablete ovisi o tjelesnoj težini psa.
• to treat flea and tick infestations in dogs and cats
• za liječenje infestacije pasa i mačaka buhama i krpeljima
The need for and frequency of re-treatment for sarcoptic mange should follow veterinary advice.
Potrebno je slijediti savjete veterinara o potrebi ponovnog liječenja i o učestalosti liječenja sarkoptoze.
If skin reactions occur, a doctor sould be consulted and the product leaflet or label shown to the doctor.
Ako se pojave kožne reakcije, potrebno je odmah potražiti liječnički savjet te liječniku pokazati uputu o VMP-u ili njegovu etiketu.
How is Bravecto used?
Kako se Bravecto primjenjuje?
For the full list of all side effects reported with Bravecto, see the package leaflet.
Potpuni popis nuspojava koje su zabilježene pri primjeni VMP-a Bravecto potražite u uputi o VMP-u.
A study conducted in Europe involved dogs with sarcoptic mange and compared Bravecto chewable tablets and Bravecto spot-on solution to another medicine authorised to treat sarcoptic mange.
Bravecto i otopina za nakapavanje Bravecto s drugim VMP-om koji je odobren za liječenje sarkoptoze.
A study conducted in Europe looked at the effectiveness of Bravecto chewable tablets and Bravecto spot-on solution in dogs with demodectic mange.
U ispitivanju provedenom u Europi na psima sa sarkoptozom uspoređene su tablete za žvakanje
Vaccinate only healthy rabbits.
Cijepite samo zdrave kuniće.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) ( http://www.ema.europa.eu/).
3732 CN De Bilt
3732 CN De Bilt Nizozemska
Revaccinate annually.
Nadocijepiti svake godine.
The excipients 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tom veterinarsko medicinskim proizvodu.
Reconstituted product: off-pink or pink coloured suspension.
Rekonstituirani proizvod: roskasta ili rozo obojena suspenzija.
The manufacture, import, possession, sale, supply and/or use of Nobivac Myxo-RHD may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Uvoz, proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena Nobivac Myxo -RHD je ili može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija sukladno nacionalnim propisima.
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Rok valjanosti liofilizata kad je zapakiran za prodaju: 2 godine.
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy.
Ispitivanjima primjene cjepiva tijekom ranog graviditeta nije dokazana neškodljivost, zato se cijepljenje ne preporuča u prvih 14 dana graviditeta.
After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Nakon infekcije s virulentnim miksoma virusom u nekih cijepljenih životinja moguć je razvoj nekoliko vrlo malih oteklina, posebno na mjestima bez dlake, koje brzo formiraju kraste.
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.
Djelatna tvar se sastoji od tvari biološkog podrijetla, namijenjena je za poticanje aktivne imunosti i nije obuhvaćena odredbama Uredbe (EK) br. 470/2009.
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur.
U vrlo rijetkim slučajevima, kod kućnih kunića mogu se javiti lokalne reakcije kao što je nekroza, krasta, kora ili gubitak dlake.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza rekonstituiranog cjepiva sadržava: Djelatna tvar:
- 1 ml and 10 ml glass vials: 4 years.
- 1 ml i 10 ml staklene bočice: 4 godine.
Any person intending to manufacture, import, possess, sell, supply and/or use Nobivac Myxo-RHD 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.
Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati Nobivac Myho-RHD mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja,
The vector technology used to develop the vaccine strain allows the RHD virus component to be produced in vitro instead of using live rabbits for cultivation.
Vektorska tehnologija koja se koristi za pripravu cjepiva, omogućuje da se RHD virusna komponenta proizvodi in vitro umjesto da se koriste živi kunići.
A transient temperature increase of 1 - 2° C can commonly occur.
Obično dolazi do prolaznog porasta temperature od 1 - 2 °C.
These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Te kraste se uočavaju kod životinja s aktivnom imunosti i nemaju utjecaj na opće zdravstveno stanje, apetit ili ponašanje kunića.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/09/2011
Datum prvog odobrenja : 07/09/2011
Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
Farmakoterapijska grupa: živo virusno cjepivo, ATCvet kod: QI08AD
The scabs usually disappear within 2 weeks after the small swellings have been observed.
Kraste obično nestanu dva tjedna nakon pojave oteklina.
Therefore, the vaccination of breeding bucks is not recommended.
Stoga se ne preporuča cijepljenje rasplodnih mužjaka.
STORAGE CONDITIONS Store in a refrigerator.
UVJETI ČUVANJA Čuvati u hladnjaku.
Solvent (50 ml PET vial):
Otapalo (50 ml PET bočice):
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Čuvati izvan pogleda i dosega djece.
In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
U vrlo rijetkim slučajevima mogu se javiti blagi klinički znakovi miksomatoze 3 tjedna nakon cijepljenja.
In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination.
U vrlo rijetkim slučajevima nakon cijepljenja se mogu javiti ozbiljne hipersenzitivne reakcije koje mogu biti fatalne.
The swelling will resolve completely by 3 weeks after vaccination.
Oteklina potpuno nestaje 3 tjedna nakon cijepljenja.
Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Hidrolizirana želatina Pankreasni digest kazeina Sorbitol
Any reconstituted vaccine remaining at the end of this time should be discarded.
preostalo nakon tog vremena, treba odbaciti.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
SADRŽAJ, IZRAŽEN MASOM, VOLUMENOM ILI BROJEM DOZA
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom koje je priloženo za primjenu s proizvodom.
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
- vrlo rijetke (manje od 1 životinje na 10,000 životinja, uključujući izolirane slučajeve).
- 50 ml PET vials: 2 years.
- 50 ml plastične PET boce: 2 godine.
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- vrlo česte (više od 1 u 10 životinja pokazuju nuspojave za vrijeme trajanja jednog tretmana)
Number of vials of freeze-dried vaccine to be added
Broj bočica liofiliziranog cjepiva, koji se mora dodati
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination.
Kunići koji su prethodno cijepljeni sa drugim mikosomatskim cjepivom ili su imali prirodnu mikosomatsku terensku infekciju ne mogu razviti odgovarajući imunološki odgovor protiv zečje hemoragijske bolesti nakon cijepljenja.
Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Otapalo: - Staklene bočice (1 ml ili 10 ml): Ne zahtijeva posebne temperaturne uvjete čuvanja.
Shelf-life after reconstitution according to directions: 4 hours
Rok valjanosti poslije rekonstitucije prema uputi: 4 sata
SPECIAL STORAGE CONDITIONS No special storage conditions.
Nema posebnih uvjeta čuvanja.
50 doses
1 doza 50 doza
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Shelf-life of the solvent as packaged for sale:
Rok valjanosti otapala kad je zapakirano za prodaju:
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Nakon rekonstitucije, 1 dozu cjepiva dati subkutano kunićima od 5 tjedana starosti nadalje.
Intervet International B.V., site Boxmeer Wim de Körverstraat 35
Intervet International BV Wim de Körverstraat 35
- PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
- PET bočice (50 ml): Čuvati u hladnjaku (2°C - 8°C).
In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
Pored znakova uočenih nakon cijepljenja s jednom dozom, blaga oteklina lokalnih limfnih čvorova može se pojaviti 3 dana nakon cijepljenja s prekomjernom dozom.
Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Naziv i adresa proizvođača biološki djelatne tvari Intervet International BV, site De Bilt
Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Živi miksoma virus, vektorski RHD soj 009: ≥103,0 i ≤106,1 FFU*
TARGET SPECIES Rabbits.
CILJNE VRSTE ŽIVOTINJA Kunići.
For active immunisation of rabbits to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
Za aktivnu imunizaciju kunića za smanjenje smrtnosti i kliničkih znakova miksomatoze i za sprječavanje smrtnosti zbog hemoragične bolesti kunića uzrokovana klasičnim sojem RHD virusa.
Solvent (1 ml and 10 ml glass vial): No special precautions for storage.
Otapalo (1 ml i 10 ml staklene bočice): Ne zahtjeva posebne uvjete čuvanja.
Shelf-life after reconstitution according to directions: 4 hours.
Rok valjanosti nakon rekonstitucije prema uputi: 4 sata.
TARGET SPECIES Rabbits
CILJNE VRSTE ŽIVOTINJA Kunići
Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Liofilizat: Staklena bočica od 1 ili 50 doza s halogenbutil gumenim čepom i aluminijskom kapicom.
Total number of rabbits that can be vaccinated
Broj kunića koje možemo cijepiti
Ensure that the lyophilisate is completely reconstituted before use.
Prije uporabe liofilizat se mora potpuno rekonstituirati.
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Čini se da u tome do određene mjere ulogu imaju nedavne ili latentne infekcije terenskim m miksoma virusom.
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
Name and address of the manufacturer responsible for batch release Intervet International B.V.
Naziv i adresa proizvođača odgovornog za puštanje serije u promet Intervet International BV
Use the vaccine suspension within 4 hours of reconstitution.
4. Suspenziju cjepiva upotrijebiti u roku od 4 sata nakon rekonstitucije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
PODACI NA VANJSKOM PAKOVANJU KUTIJA ( OTAPALO)
PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Nobivac Myxo-RHD liofilizat i otapalo za suspenziju za injekciju za kuniće
Vaccine: Store in a refrigerator (2 °C - 8 °C).
Cjepivo: čuvati u hladnjaku (2°C - 8°C).
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
Liofilizat i otapalo za suspenziju za injekciju.
Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) vial of 50 ml closed with a halogenobutyl rubber stopper and aluminium cap.
Staklena bočica od 1 ml ili 10 ml, ili plastična bočica od polietilen tereftalata (PET) od 50 ml s halogenbutil gumenim čepom i aluminijskom kapicom.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Živi miksoma virus, vektorski RHD soj 009, ≥103,0 FFU*/doza.
Disodium phosphate dihydrate
Dinatrijev fosfat dihidrat
4.2 Indications for use, specifying the target species For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
Za aktivnu imunizaciju kunića u dobi od 5 tjedana i više, za smanjenje smrtnosti i kliničkih znakova miksomatoze i za sprječavanje smrtnosti zbog hemoragične bolesti kunića uzrokovane klasičnim sojem RHD virusa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Cjepni soj je miksoma virus, koji sadrži gen za kapsidni protein virusa hemoragične bolesti kunića.
A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
U prva dva tjedna nakon cijepljenja, na mjestu injiciranja često nastaje manja oteklina koja nije bolna (najvećeg promjera do 2 cm).
Lyophilisate: off-white or cream-coloured pellet.
Liofilizat: bjelkasta do kremasta peleta.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA Pročitati uputu o VMP prije primjene.
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Rekonstituirani koncentrat cjepiva izvući iz bočice(a) i vratiti u bočicu s Nobivac Myxo RHD
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Plodnost: Ispitivanja neškodljivosti na reprodukciju mužjaka nisu provedena.
− rare (more than 1 but less than 10 animals in 10,000 animals)
- rijetke (više od 1 ali manje od 10 životinja na 10,000 životinja)
Cardboard box with 10 x 10 ml solvent vials (glass)
Kartonska kutija sa 10x10 ml (staklenih) bočica otapala
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Rekonstituirati bočicu s jednom dozom cjepiva s 1 ml Nobivac Myxo RHD otapala i upotrijebiti sav sadržaj bočice.
4.1 Target species
4.2 Indikacije za primjenu, navesti ciljne vrste životinja
NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Nobivac Myxo-RHD
Plastic box with 5 x 1 dose of vaccine including 5 x 1 ml solvent vials (glass) Plastic box with 25 x 1 dose of vaccine including 25 x 1 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Plastična kutija s 5 x 1 dozom cjepiva i 5x1 ml (staklenih) bočica otapala Plastična kutija s 25 x 1 dozom cjepiva i 25x1 ml (staklenih) bočica otapala
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Za poticanje imunosti protiv virusa miksomatoze i virusa hemoragične bolesti kunića.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Paziti da se nastala suspenzija cjepiva u bočici s Nobivac Myxo RHD otapalom dobro promiješa.
5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine + 10 x 10 ml glass solvent vials 10 x 50 doses of vaccine + 2 x 50 ml PET solvent vials
25 x 1 doza cjepiva i otapala 10 x 50 doza cjepiva ; 10 ml staklena bočica s otapalom 10 x 50 doza cjepiva -;50 ml PET bočica s otapalom
4.4 Special warnings for each target species
12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja:
Cardboard box with 1 x 50 ml solvent vials (PET)
Kartonska kutija sa 1x50 ml (PET) bočica otapala
Solvent
KARENCIJA
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/001-004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/132/001-004
− uncommon (more than 1 but less than 10 animals in 1,000 animals)
- manje česte (više od 1 ali manje od 10 životinja na 1000 životinja)
As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
Tako su kunići imunizirani i protiv miksoma virusa i protiv virusa hemoragične bolesti kunića.
ADVICE ON CORRECT ADMINISTRATION Ensure that the lyophilisate is completely reconstituted before use.
Prije primjene liofilizat se mora potpuno rekonstituirati.
WITHDRAWAL PERIOD Zero days.
Karencija: nula dana
Single-dose vial
Višedozna bočica
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
Miksoma virus, živi, vektorski RHD
Injection volume
Količina otapala
Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Za pravilnu rekonstituciju višedozne bočice, koristiti sljedeći postupak: 1. Dodati 1 - 2 ml Nobivac Myxo RHD otapala u bočicu(e) s 50 doza cjepiva i paziti da se liofilizat potpuno otopi.
Single dose vial
Bočice s pojedinačnom dozom
PACKAGE SIZE 1 x 50 ml
VELIČINA PAKOVANJA 1x 50 ml CILJNE VRSTE ŽIVOTINJA Kunići
EXPIRY DATE EXP {month/year} Once reconstituted use within 4 hours.
Rekonstituirano cjepivo upotrijebiti unutar 4 sata.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/132/004
- Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Plastična kutija s bočicom od 25 x 1 dozom cjepiva i 25 x 1 ml otapala.
- Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Plastična kutija s bočicom od 5 x 1 dozom cjepiva i 5 x 1 ml otapala.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/132/003
Fertility:
Otapalo:
- Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Kartonska kutija s bočicom od 10 x 50 doza cjepiva; 2 x kartonske kutije od koje svaka po 50 ml otapala.
- Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Kartonska kutija s bočicom od 10 x 50 doza cjepiva; kutija s 10 bočica x 10 ml otapala.