natgillin/translations-raw huggingface dataset:
Ако се проявят кожни реакции, консултирайте се с лекар и покажете опаковката на продукта.
If skin reactions occur, a doctor sould be consulted and the product leaflet or label shown to the doctor.
За оптимален контрол на опаразитяване с бълхи лечението трябва да се повтаря на всеки дванадесет седмици.
Treatment should be repeated every twelve weeks for optimal flea control.
Европейската комисия издава лиценз за употреба на Bravecto, валиден в ЕС.
Bravecto received a marketing authorisation valid throughout the EU on 11 February 2014.
Zaščitite pred svetlobo.
Protect from light.
DATUM REVIZIJE BESEDILA
DATE OF REVISION OF THE TEXT
Prehodno povišanje temperature za 1-2° C se lahko pogosto pojavi.
A transient temperature increase of 1 - 2° C can commonly occur.
Cepljenje ponovimo vsako leto.
Revaccinate annually.
4.6 Neželeni učinki (pogostost in resnost)
4.6 Adverse reactions (frequency and seriousness)
DRUGE INFORMACIJE
OTHER INFORMATION
Nizozemska
The Netherlands
sme zmrzniti.
Do not freeze.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Subkutana uporaba.
Subcutaneous use.
Rekonstituirano cepivo, ki po tem času še ostane, je treba zavreči.
Any reconstituted vaccine remaining at the end of this time should be discarded.
Cepite samo zdrave kunce.
Vaccinate only healthy rabbits.
EXP {mesec/leto}
EXPIRY DATE EXP {month/year}
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila Nobivac Mixo-RHD je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
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.
Pogostost neželenih učinkov je določena po naslednjem dogovoru:
The frequency of adverse reactions is defined using the following convention:
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila ali po njej odločamo od primera od primera.
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.
s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
FARMACEVTSKA OBLIKA
PHARMACEUTICAL FORM
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Interaction with other medicinal products and other forms of interaction:
Liofilizat se mora pred uporabo popolnoma rekonstituirati.
Ensure that the lyophilisate is completely reconstituted before use.
Uporabite suspenzijo cepiva v 4 urah po rekonstituciji.
Use the vaccine suspension within 4 hours of reconstitution.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
PROHIBITION OF SALE, SUPPLY AND/OR USE
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
DODATEK II
ANNEX II
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
Overdose (symptoms, emergency procedures, antidotes):
Shranjujte v hladilniku.
STORAGE CONDITIONS Store in a refrigerator.
Pri hišnih kuncih v zelo redkih primerih lahko pride do lokalnih reakcij, kot so nekroza, kraste ali izpadanje dlake.
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z vehiklom, ki je priložen za uporabo s tem cepivom.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Vektorska tehnologija, ki se uporablja za pripravo seva cepiva, omogoča, da se RHD virusna komponenta proizvaja in vitro, namesto da bi uporabili žive kunce.
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.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
INDIKACIJA(E)
INDICATION(S)
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE SMISELNO
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Oteklina popolnoma izgine v treh tednih po cepljenju.
The swelling will resolve completely by 3 weeks after vaccination.
Zdi se, da imajo pri tem do določene mere vlogo nedavne ali latentne infekcije z miksoma virusom.
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
4.4 Posebna opozorila za vsako ciljno vrsto
4.4 Special warnings for each target species
Zdravilna učinkovina, ki je biološkega izvora in je namenjena za vzbujanje aktivne imunosti, ni zajeta v Uredbi (ES) št.
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.
Število vial liofiliziranega cepiva, ki jih je treba dodati
Number of vials of freeze-dried vaccine to be added
Zato cepljenje plemenskih samcev ni priporočljivo.
Therefore, the vaccination of breeding bucks is not recommended.
Trajanje imunosti: 1 leto
Duration of immunity: 1 year.
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenje ni priporočljivo v prvih 14 dneh brejosti.
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy.
Nič dni.
Zero days.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
4.7 Use during pregnancy and lactation
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
SPECIAL WARNING(S), IF NECESSARY
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure
Shelf-life after reconstitution according to directions: 4 hours
Vsak odmerek rekonstituiranega cepiva vsebuje:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains:
zelo redkih primerih se lahko pojavijo hude preobčutljivostne reakcije, ki so lahko smrtne.
In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination.
Rekonstituirano cepivo: rozasta ali roza suspenzija.
Reconstituted product: off-pink or pink coloured suspension.
Število kuncev, ki jih lahko cepimo
Total number of rabbits that can be vaccinated
Samo za živali.
For animal treatment only.
IMUNOLOŠKE LASTNOSTI
IMMUNOLOGICAL PROPERTIES
EXP {mesec/leto} Rekonstituiran cepivo porabite v 4 urah.
EXPIRY DATE EXP {month/year} Once reconstituted use within 4 hours.
EU/2/11/132/002 EU/2/11/132/003 EU/2/11/132/004
EU/2/11/132/001 EU/2/11/132/002 EU/2/11/132/003 EU/2/11/132/004
BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Za pravilno rekonstitucijo večodmerne viale ravnajte, kot sledi:
For proper reconstitution of the multidose vial, use the following procedure:
Začetek imunosti: 3 tedni
Onset of immunity: 3 weeks.
- 1 ml in 10 ml steklene viale: 4 leta
- 1 ml and 10 ml glass vials: 4 years.
Ni posebnih pogojev shranjevanja.
SPECIAL STORAGE CONDITIONS No special storage conditions.
KONTRAINDIKACIJE
CONTRAINDICATIONS
Pred uporabo preberite navodilo za uporabo.
Read the package leaflet before use.
Ime in naslov izdelovalca, odgovornega za sprostitev serije Intervet International BV
Name and address of the manufacturer responsible for batch release Intervet International B.V.
Pomožne snovi:
Active substance:
cepljenih živalih lahko pojavi nekaj zelo majhnih oteklin, posebno na neporaščenih delih telesa, ki se hitro
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.
V zelo redkih primerih se v treh tednih po cepljenju lahko pojavijo blagi klinični znaki miksomatoze.
In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (SAMO VEHIKEL)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
Ni nujno, da so v prometu vsa navedena pakiranja.
Not all pack sizes may be marketed.
NAČIN IN POT(I) UPORABE
METHOD AND ROUTE(S) OF ADMINISTRATION
POSEBNA OPOZORILA Posebna opozorila za uporabo pri živalih:
Special precautions for use in animals:
natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KLINIČNI PODATKI 4.1 Ciljne živalske vrste
4.1 Target species
Jih ni.
None.
VELIKOST PAKIRANJA 1 x 50 ml
PACKAGE SIZE 1 x 50 ml
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Po rekonstituciji dajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
4.8 Medsebojno delovanje z drugimi zdravili
4.8 Interaction with other medicinal products and other forms of interaction
Poskrbite, da je nastala suspenzija cepiva v viali z Nobivac Myxo-RHD vehiklom dobro premešana.
Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Shranjujte v hladilniku (2 °C - 8 °C).
Store in a refrigerator (2 °C - 8 °C).
4.9 Odmerjanje in pot uporabe
4.9 Amounts to be administered and administration route
Steklena viala z 1 ali 50 odmerki zaprta z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Intervet International BV, site Boxmeer Wim de Körverstraat 35
Intervet International B.V., site Boxmeer Wim de Körverstraat 35
ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Inkompatibilnosti
Incompatibilities:
VELIKOST PAKIRANJA 10 x 10 ml
PACKAGE SIZE 10 x 10 ml
Vehikel (50 ml viala iz PET):
Solvent (50 ml PET vial):
Rok uporabnosti liofilizata v pakiranju za prodajo:
Shelf-life of the solvent as packaged for sale:
Za aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), ki jo povzroča klasični
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.
50 ml viala
50 ml vial
VELIKOST PAKIRANJA
PACKAGE SIZE
Vehikel: bistra brezbarvna raztopina.
Solvent: clear colourless solution.
Za aktivno imunizacijo kuncev od 5 tednov starosti dalje za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), ki jo povzroča klasični RHD sev virusa.
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.
37/2010 navaja, da se MRL ne zahtevajo, ali pa velja, da niso zajete v Uredbo (ES) št.
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.
- 1 ml in 10 ml viale
1 ml and 10 ml vial
Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev.
The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
ATCvet:
Lyophilisate:
- viale iz PET: Shranjujte v hladilniku (2 °C - 8 °C).
- PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
in ne vplivajo na splošno zdravje, tek ali obnašanje kunca.
These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
50 odmerkov
50 doses
s kakšnim drugim cepivom proti miksomatozi ali ki so preboleli miksomatozo, po cepljenju ne bo prišlo do pravega imunskega odgovora na hemoragično bolezen kuncev.
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.
Rekonstituirajte vialo z enim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale.
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
CILJNE ŽIVALSKE VRSTE
TARGET SPECIES Rabbits
Na veterinarski recept.
To be supplied only on veterinary prescription.
Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo.
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Liofilizat in vehikel za suspenzijo za injiciranje
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
- zelo pogosti (pri več kot 1 živali od 10 živali v teku enega zdravljenja)
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
ŠTEVILKA(E) DOVOLJENJA
MARKETING AUTHORISATION NUMBER(S)
Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac Myxo-RHD vehiklom.
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo Nobivac Mixo-RHD, se mora posvetovati
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.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
shranjujte v hladilniku (2 °C - 8 °C).
Vaccine: Store in a refrigerator (2 °C - 8 °C).
KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
2 leti Rok uporabnosti vehikla v pakiranju za prodajo:
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Indikacije za uporabo pri ciljnih živalskih vrstah
Special precautions for use in animals
Za stimuliranje imunosti proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju
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.
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
4.5 Special precautions for use
hidrolizirana želatina pankreasni presnovek kazeina sorbitol natrijev hidrogenfosfat dihidrat
Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Intervet International BV, site De Bilt Ambachtstraat 4
Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Večodmerna viala
Multi-dose vial
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Cepivo:
Pregnancy:
Poleg neželenih učinkov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
10 x 50 odmerkov cepiva + 10 x 10 ml steklene viale z vehiklom 10 x 50 odmerkov cepiva + 2 x 50 ml viale iz PET z vehiklom
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
Brejost Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenje v prvih 14
Studies involving the use of the vaccine during early pregnancy were inconclusive.
imunološka zdravila za leporide, živo virusno cepivo, oznaka
Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
Brejost
Solvent
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
6.1 List of excipients
IME VEHIKLA Nobivac Myxo-RHD Vehikel
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD
V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Steklena viala z 1 ml ali 10 ml, ali viala iz polietilen tereftalata (PET)
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.
Nobivac Myxo-RHD
NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Serija {številka}
BATCH NUMBER Lot {number}
- steklene viale (1 ml ali 10 ml):
Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Kunci.
Rabbits.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
C. STATEMENT OF THE MRLs
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/09/2011
Vehikel:
Fertility:
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MALIH STIČNIH
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
(kartonska škatla z 10 x 10 ml vialami (stelenimi) z vehiklom
Cardboard box with 10 x 10 ml solvent vials (glass)
toda manj kot 10 živalih od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
(kartonska škatla z 1 x 50 ml vialo (PET) z vehiklom
Cardboard box with 1 x 50 ml solvent vials (PET)
Kraste navadno izginejo v dveh
The scabs usually disappear within 2 weeks after the small swellings have been observed.
cepiva + kartonska škatla z 10 x vialo z 10 ml vehikla.
- Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Zdravilo shranjujte nedosegljivo otrokom.
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
s 25 x 1 odmerek cepiva in 25 x 1 vialo (stekleno) z vehiklom Kartonska škatla z 10 x 50 odmerki cepiva
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
Vehikel ne
Single-dose vial
ZA PROMET EU/2/11/132/004
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
s 25 x vialo z 1 odmerkom cepiva in 25 x vialo z 1 ml vehikla.
- Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
STATEMENT OF THE MRLs
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
ZA PROMET EU/2/11/132/003
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla.
- Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: belkasta ali krem peleta.
Lyophilisate: off-white or cream-coloured pellet.
Število vial
Volume
Miksoma virus, živi vektorski RHD sev 009: ≥10
Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Po rekonstituciji dajte1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
toda manj kot 10 živalih od 1000 živali) - redki (pri več kot 1
− rare (more than 1 but less than 10 animals in 10,000 animals)
- 50 ml viale iz PET: 2 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure
- 50 ml PET vials: 2 years.
cepiva + 2 x kartonski škatli, vsaka z vialo
- Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
toda manj kot 10 živalih od 100 živali) - občasni (pri več kot 1
− common (more than 1 but less than 10 animals in 100 animals)
Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v vialo/e
Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Nobivac Myxo-RHD liofilizat
PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Večodmerna viala Količina
Injection volume
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
WITHDRAWAL PERIOD
s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla - Plastična škatla
Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
OVOJNINI NALEPKA ZA VEHIKEL
MANUFACTURER'S BATCH NUMBER Lot {number}
Datum zadnjega podaljšanja:
WITHDRAWAL PERIOD Withdrawal period: Zero days.
ZA PROMET Z ZDRAVILOM
PHARMACEUTICAL PARTICULARS
NEŽELENI UČINKI
ADVERSE REACTIONS
POSEBNO(A) OPOZORILO(A), ČE JE(SO) POTREBNO(A)
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Viala z enkratnim odmerkom
Single dose vial
Vrsta ovojnine in vsebina
6.5 Nature and composition of immediate packaging