natgillin/translations-raw huggingface dataset:
In case of spillage on table or floor surfaces, excess Bravecto spot-on solution should be removed using paper tissue and the area cleaned with a detergent. 
V primeru razlitja po mizi ali talnih površinah zdravilo Bravecto v obliki raztopine za kožni nanos odstranite s papirnatimi brisačami in očistite površino s čistilom.
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. 
Najpogostejši neželeni učinek raztopine za kožni nanos (ki lahko prizadene več kot 1 žival od 100) je blaga prehodna kožna reakcija na mestu nanosa, kot sta eritem (pordelost) in pruritus (srbenje) ali izguba dlak.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor. 
Če človek zdravilo nenamerno zaužije, se mora nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
How is Bravecto used? 
Kako se zdravilo Bravecto uporablja?
As demodectic mange is caused by a number of factors, it is advisable for any underlying disease to be treated. 
Ker garjavost vrste Demodex canis povzroča več dejavnikov, je treba zdraviti tudi vsa sočasna obolenja.
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. 
Zdravilo Bravecto in primerjano zdravilo sta bila 100-odstotno učinkovita, saj pri nobenem psu v postružkih kože, odvzetih 56 in 84 dni po zdravljenju, niso našli živih garjavcev.
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. 
Terenska študija je pokazala, da je bilo zdravilo Bravecto učinkovito pri zmanjšanju števila bolh in klopov pri psih, ki so bili infestirani z bolhami ali klopi, in da so njegovi učinki proti bolham in večini vrst klopov trajali tri mesece.
• to treat ear mite infestations in cats. 
• za zdravljenje infestacij z ušesnimi garjami pri mačkah.
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. 
Vsebina polne merilne kapalke zdravila Bravecto se nanese na kožo psa ali mačke, in sicer med lopatice pri psu in na spodnji del lobanje pri mački.
After being given, its actions last for 12 weeks against fleas and 8 to 12 weeks against ticks. 
Po uporabi zdravilo proti bolham deluje 12 tednov, proti klopom pa od osem do 12 tednov.
The spot-on solution and tablets are available in different strengths for dogs and cats of different weights. 
Raztopina za kožni nanos in tablete so na voljo v različnih jakostih za pse in mačke z različnimi telesnimi masami.
• to treat flea and tick infestations in dogs and cats 
• za zdravljenje infestacij z bolhami in klopi pri psih in mačkah;
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. 
V terenski študiji, ki so jo opravili v EU in v katero je bilo vključenih 561 psov z bolhami in/ali klopi, so učinke zdravila Bravecto v obliki tablet primerjali z učinki drugega zdravila za uničenje bolh in klopov, fipronila, ki se v obliki raztopine za kožni nanos nanese na kožo psov.
Bravecto can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Bravecto je le na recept.
If skin reactions occur, a doctor sould be consulted and the product leaflet or label shown to the doctor. 
Če pride do reakcij na koži, se je treba posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali nalepko.
In a study conducted in the EU involving cats with ear mites, the effectiveness of Bravecto was >90% based on presence of live ear mites at day 28 after treatment. 
V študiji, ki so jo opravili v EU in v katero so bile vključene mačke z ušesnimi garjami, so z določanjem prisotnosti živih ušesnih garjavcev 28 dni po zdravljenju za zdravilo Bravecto ugotovili več kot 90odsotno učinkovitost.
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. 
Zdravilo Bravecto je na voljo v obliki raztopine za kožni nanos v merilni kapalki za uporabo pri psih in mačkah ter v obliki žvečljivih tablet za uporabo pri psih.
The animal's application site should no longer be noticeable before resuming contact with the site of application. 
Pred nadaljnjimi stiki z mestom nanosa slednje na živali ne sme biti več opazno.
Bravecto tablets are given around the dog's feeding time as a tablet of the appropriate strength for the dog's bodyweight. 
Zdravilo Bravecto v obliki tablet se daje približno v času hranjenja, pri čemer se uporabi ena tableta, katere jakost ustreza telesni masi psa.
• to treat demodectic and sarcoptic mange (skin infestation caused by two different mites) in dogs 
• za zdravljenje infestacij z garjavci vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) pri psih;
Treatment should be repeated every twelve weeks for optimal flea control. 
Za optimalen nadzor nad bolhami je treba zdravljenje ponoviti vsakih 12 tednov.
The pipette to use is selected on the basis of the dog or cat's weight. 
Merilno kapalko je treba izbrati na podlagi telesne mase psa ali mačke.
Bravecto kills fleas within 8 hours and ticks within 12 hours in dogs. 
Pri psih zdravilo Bravecto bolhe uniči v osmih urah, klope pa v 12 urah.
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. 
V študiji, ki so jo opravili v EU in v katero so bili vključeni psi z infestacijo z garjavci vrste Sarcoptes scabiei, so primerjali zdravilo Bravecto v obliki žvečljivih tablet in v obliki raztopine za kožni nanos z drugim zdravilom, odobrenim za zdravljenje te vrste garjavosti.
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, ki je bila opredeljena kot odstotek psov brez živih garjavcev 56 in 84 dni po zdravljenju, je bila za zdravilo Bravecto v obliki žvečljivih tablet 95-odstotna, v obliki raztopine za kožni nanos pa 94-odstotna.
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. 
V dveh drugih terenskih študijah, ki so ju opravili v EU in sta vključevali pse in mačke, infestirane z bolhami in/ali klopi, so primerjali učinke zdravila Bravecto v obliki raztopine za kožni nanos s fipronilom v obliki raztopine za kožni nanos.
A single treatment is required for demodectic and sarcoptic mange in dogs and ear mites in cats. 
Za zdravljenje infestacij z garjavci vrste Demodex canis in Sarcoptes scabiei pri psih in infestacij z ušesnimi garjami pri mačkah se opravi eno zdravljenje.
Treatment should be repeated every 12 weeks for optimal flea and tick control. 
Za optimalen nadzor nad bolhami in klopi je treba zdravljenje ponoviti vsakih 12 tednov.
A study conducted in Europe looked at the effectiveness of Bravecto chewable tablets and Bravecto spot-on solution in dogs with demodectic mange. 
V študiji, ki so jo opravili v EU, so preučevali učinkovitost zdravila Bravecto v obliki žvečljivih tablet in v obliki raztopine za kožni nanos pri psih z infestacijo z garjavci vrste Demodex canis.
If skin contact occurs, the affected area should be washed immediately with soap and water 
Pri stiku kože z zdravilom je treba kožo nemudoma sprati z milom in vodo.
Suitable gloves should be worn when handling or giving Bravecto spot-on solution to dogs and cats. 
Pri uporabi ali dajanju zdravila v obliki raztopine za kožni nanos pri psih in mačkah nosite ustrezne rokavice.
The need for and frequency of re-treatment for sarcoptic mange should follow veterinary advice. 
Pri garjavosti vrste Demodex canis mora veterinar presoditi o potrebi po ponovitvi zdravljenja in njegovi pogostosti.
After being given, its actions last for 12 weeks against fleas and ticks. 
Po nanosu zdravilo proti bolham in klopom deluje 12 tednov.
Revaccinate annually. 
Cepljenje ponovimo vsako leto.
Any reconstituted vaccine remaining at the end of this time should be discarded. 
Rekonstituirano cepivo, ki bi po tem času še ostalo, je treba zavreči.
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. 
Pomožne snovi, ki so navedene v poglavju 6.1 Povzetka glavnih značilnosti zdravila, so bodisi dovoljene učinkovine, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 navaja, da se MRL ne zahtevajo, ali pa velja, da niso zajete v Uredbo (ES) št. 470/2009, kadar se uporabljajo tako kot v tem zdravilu za uporabo v veterinarski medicini.
Vaccinate only healthy rabbits. 
Cepite samo zdrave kunce.
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. 
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati Nobivac Myxo-RHD, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
The scabs usually disappear within 2 weeks after the small swellings have been observed. 
Kraste navadno izginejo v dveh tednih po tem, ko smo opazili male otekline.
Duration of immunity: 1 year. 
Trajanje imunosti: 1 leto
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 opazimo samo pri živalih z aktivno imunostjo in ne vplivajo na splošno zdravje, tek ali obnašanje kunca.
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy. 
Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenja ne priporočamo v prvih 14 dneh brejosti.
Use the vaccine suspension within 4 hours of reconstitution. 
Uporabite suspenzijo cepiva v 4 urah po rekonstituciji.
Therefore, the vaccination of breeding bucks is not recommended. 
Zato cepljenja plemenskih samcev ne priporočamo.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z vehiklom, ki je priložen za uporabo s tem cepivom.
Ensure that the lyophilisate is completely reconstituted before use. 
Liofilizat se mora pred uporabo popolnoma rekonstituirati.
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, ki se uporablja za pripravo seva cepiva, omogoča, da se RHD virusna komponenta proizvaja in vitro, namesto da bi uporabili žive kunce.
STORAGE CONDITIONS Store in a refrigerator. 
Shranjujte v hladilniku.
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. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina, ki je biološkega izvora in je namenjena za vzbujanje aktivne imunosti, ni zajeta v Uredbi (ES) št. 470/2009.
The swelling will resolve completely by 3 weeks after vaccination. 
Oteklina popolnoma izgine v treh tednih po cepljenju.
Number of vials of freeze-dried vaccine to be added 
Število vial liofiliziranega cepiva, ki jih moramo dodati
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, prodaja, oskrba in/ali uporaba Nobivac Myxo-RHD je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent. 
Zdi se, da imajo pri tem do določene mere vlogo nedavne ali latentne infekcije z miksoma virusom.
4.7 Use during pregnancy and lactation 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Total number of rabbits that can be vaccinated 
Število kuncev, ki jih lahko cepimo
Onset of immunity: 3 weeks. 
Začetek imunosti: 3 tedni
In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination. 
V zelo redkih primerih se v treh tednih po cepljenju lahko pojavijo blagi klinični znaki miksomatoze.
Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD 
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: živo virusno cepivo, oznaka ATCvet: QI08AD
In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination. 
V zelo redkih primerih se lahko pojavijo hude preobčutljivostne reakcije, ki so lahko smrtne.
Do not use this veterinary medicinal product after the expiry date which is stated on the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na steklenički.
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur. 
Pri hišnih kuncih v zelo redkih primerih lahko pride do lokalnih reakcij, kot so nekroza, kraste ali izpadanje dlake.
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. 
Po okužbi z miksoma virusom se pri nekaterih cepljenih živalih lahko pojavi nekaj zelo majhnih oteklin, posebno na neporaščenih delih telesa, ki se hitro spremenijo v kraste.
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards. 
Po rekonstituciji injicirajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
SPECIAL STORAGE CONDITIONS No special storage conditions. 
Za shranjevanje ni posebnih navodil.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: 
Vsak odmerek rekonstituiranega cepiva vsebuje:
Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage. 
- viale (1 ml ali 10 ml): Za shranjevanje ni posebnih navodil.
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. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo kuncev od 5 tednov starosti dalje za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev virusa.
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. 
Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju s prevelikim odmerkom opazimo rahlo oteklino lokalnih limfnih vozlov.
Shelf-life of the lyophilisate as packaged for sale: 2 years. 
Rok uporabnosti liofilizata v pakiranju za prodajo: 2 leti Rok uporabnosti vehikla v pakiranju za prodajo:
Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed. 
Poskrbite, da je nastala suspenzija cepiva v viali z Nobivac Myxo-RHD vehiklom dobro premešana.
Name and address of the manufacturer responsible for batch release Intervet International B.V. 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Intervet International BV
1 ml and 10 ml vial 
1 ml in 10 ml viale
EXPIRY DATE EXP {month/year} 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP { mesec/leto }
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. 
Pri kuncih, ki so bili predhodno cepljeni s kakšnim drugim cepivom proti miksomatozi ali ki so preboleli miksomatozo, po cepljenju ne bo prišlo do pravega imunskega odgovora na hemoragično bolezen kuncev.
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 aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev virusa.
TARGET SPECIES Rabbits 
CILJNE ŽIVALSKE VRSTE
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. 
Viala z 1 ml ali 10 ml, ali plastenka iz polietilen tereftalata (PET) s 50 ml z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved. 
Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v plastenko/e s 50 odmerki cepiva in poskrbite, da se liofilizat popolnoma raztopi.
Vaccine: Store in a refrigerator (2 °C - 8 °C). 
Cepivo: shranjujte v hladilniku (2 °C - 8 °C).
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial. 
Rekonstituirajte vialo z enkratnim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale.
- PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C). 
Vehikel (50 ml plastenak iz PET): Shranjujte v hladilniku (2 °C - 8 °C).
PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits 
Nobivac Myxo-RHD liofilizat in vehikel za suspenzijo za injiciranje za kunce
The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus. 
Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev.
No safety study on the reproductive performance has been conducted in male rabbits (bucks). 
Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
• Pogoji ali omejitve glede varne in učinkovite uporabe zdravila za uporabo v veterinarski medicini
Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap. 
Viala z 1 ali 50 odmerki z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection 
Liofilizat in vehikel za suspenzijo za injiciranje
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial. 
Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac MyxoRHD vehiklom.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose. 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10
Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi hidrolizirana želatina pankreasni presnovek kazeina sorbitol dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
− very rare (less than 1 animal in 10,000 animals, including isolated reports). 
- občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD 
IME VEHIKLA Nobivac Myxo-RHD vehikel
- 1 ml and 10 ml glass vials: 4 years. 
• 1 ml in 10 ml steklene viale: 4 leta • 50 ml plastenke iz PET: 2 leti
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus. 
KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD
For proper reconstitution of the multi-dose vial, use the following procedure: 
Za pravilno rekonstitucijo večodmerne plastenke ravnajte, kot sledi: 1.
A small, non-painful swelling (max. 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. 
Lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus. 
Za stimulacijo imunosti proti virusu miksomatoze in proti virusu hemoragične bolezni kuncev.
As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus. 
Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
Solvent (50 ml PET vial): 
Vehikel (1 ml and 10 ml viala):
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Multi-dose vial 
Večodmerne plastenke Količina vehikla
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali)
Solvent 
Odmerek
Single dose vial 
Viale z enkratnim odmerkom
Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4 
Intervet International BV, site De Bilt
PHARMACEUTICAL PARTICULARS 
Sistem farmakovigilance
Fertility: 
Vehikel:
- Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent. 
Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla.
- Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent. 
Zloženka s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Injection volume 
Več odmerkov
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 
5 x 1 odmerek cepiva z vehiklom 25 x 1 odmerek cepiva z vehiklom 10 x 50 odmerkov cepiva - 10 ml viale z vehiklom
Pregnancy: 
Pakiranja:
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 
Zloženka s 5 x vialo z 1 odmerkom cepiva in 5x vialo z 1 ml vehikla Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla
Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units 
Miksoma virus, živi vektorski RHD sev 009: ≥10