Ultifend ND IBD

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970

Active ingredient:

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Available from:

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

ATC code:

QI01AD16

INN (International Name):

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Therapeutic group:

Embryonated chicken eggs; Chicken

Therapeutic area:

Ónæmissjúkdómar fyrir fugla

Therapeutic indications:

For the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by Newcastle disease virus (NDV) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (IBDV); to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus (MDV).

Authorization status:

Leyfilegt

Authorization date:

2021-04-20

Patient Information leaflet

                                14
B. FYLGISEÐILL
15
FYLGISEÐILL:
Ultifend ND IBD stungulyfsþykkni og leysir, dreifa, fyrir hænsni
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi og framleiðandi sem ber ábyrgð á lokasamþykkt:
Ceva-Phylaxia Co. Ltd.
1107 Budapest
Szállás u. 5.
Ungverjaland
2.
HEITI DÝRALYFS
Ultifend ND IBD stungulyfsþykkni og leysir, dreifa, fyrir hænsni.
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Hver skammtur (0,05 ml eða 0,2 ml) inniheldur:
Virkt innihaldsefni:
Frumutengd, lifandi kalkúnaherpesveira (rHVT/ND/IBD), framleidd með
raðbrigðaerfðatækni, sem
tjáir samrunaprótein Newcastleveikiveiru (Newcastle disease virus)
og VP2-prótein
gumboroveikiveiru (infectious bursal disease virus):
að lágmarki 4.000, að hámarki 12.000 PFU
*
*
PFU = skellumyndandi einingar (plaque forming units)
Þykkni: gulbrúnleitt, einsleitt þykkni
Leysir: tær, rauðgul eða rauð lausn
4.
ÁBENDING(AR)
Til virkrar ónæmingar hjá eins dags gömlum hænuungum eða 18 daga
gömlum frjóvguðum
hænueggjum:
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum af völdum
Newcastleveikiveiru (Newcastle disease virus, NDV) og minnka
veirulosun
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum í búrsa vegna mjög
smitandi gumboroveikiveiru (infectious bursal disease virus, IBDV)
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum af völdum venjulegrar
hænsnalömunarveiru (Marek disease virus, MDV).
Ónæmi myndast eftir:
Eldiskjúklingar
NDV: 4 vikur
IBDV: 3 vikur
MDV: 9 daga
Varphænsni
NDV: 4 vikur
IBDV: 4 vikur
MDV: 9 daga
16
Ónæmi endist í:
Eldiskjúklingar
NDV: 9 vikur
IBDV: 9 vikur
MDV: ævilangt
Varphænsni
NDV: 18 vikur
IBDV: 9 vikur
MDV: ævilangt
5.
FRÁBENDINGAR
Engar.
6.
AUKAVERKANIR
Engar þekktar.
Gerið dýralækni viðvart ef vart verður einhverra aukaverkana,
jafnvel aukaverkana sem ekki eru
tilgreindar í fylgiseðlinum eða ef svo virðist sem 
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Ultifend ND IBD stungulyfsþykkni og leysir, dreifa, fyrir hænsni
2.
INNIHALDSLÝSING
Hver skammtur (0,05 ml eða 0,2 ml) inniheldur:
Virk innihaldsefni:
Frumutengd, lifandi kalkúnaherpesveira (rHVT/ND/IBD), framleidd með
raðbrigðaerfðatækni, sem
tjáir samrunaprótein Newcastleveikiveiru (Newcastle disease virus)
og VP2-prótein
gumboroveikiveiru (infectious bursal disease virus):
að lágmarki 4.000, að hámarki 12.000 PFU
*
*
PFU = skellumyndandi einingar (plaque forming units)
Hjálparefni:
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Stungulyfsþykkni og leysir, dreifa
Þykkni: gulbrúnleitt, einsleitt þykkni
Leysir: tær, rauðgul eða rauð lausn
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
Dýrategundir
Hænsni og frjóvguð hænuegg.
4.2
Ábendingar fyrir tilgreindar dýrategundir
Til virkrar ónæmingar hjá eins dags gömlum hænuungum eða 18 daga
gömlum frjóvguðum
hænueggjum:
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum af völdum
Newcastleveikiveiru (Newcastle disease virus, NDV) og minnka
veirulosun
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum í búrsa vegna mjög
smitandi gumboroveikiveiru (infectious bursal disease virus, IBDV)
•
til að draga úr dánartíðni, klínískum einkennum og
vefjaskemmdum af völdum venjulegrar
hænsnalömunarveiru (Marek disease virus, MDV).
Ónæmi myndast eftir:
Eldiskjúklingar
NDV: 4 vikur
IBDV: 3 vikur
MDV: 9 daga
Varphænsni
NDV: 4 vikur
IBDV: 4 vikur
MDV: 9 daga
3
Ónæmi endist í:
Eldiskjúklingar
NDV: 9 vikur
IBDV: 9 vikur
MDV: ævilangt
Varphænsni
NDV: 18 vikur
IBDV: 9 vikur
MDV: ævilangt
4.3
Frábendingar
Engar.
4.4
Sérstök varnaðarorð fyrir hverja dýrategund
Einungis skal bólusetja heilbrigð dýr.
Myndun ónæmis gegn IBD hjá hænuungum sem eru með mjög mikið
magn mótefna gegn IBDV eða
MDV frá móður, getur seinkað um um það bil eina viku, þegar
þeir eru bólusettir með þessu dýralyfi.
4
                                
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Similar products

Active ingredient Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant

ATC code QI01AD16

QI01AD16

Marketed by Ceva-Phylaxia Veterinary Biologicals Co. Ltd

Ceva-Phylaxia Veterinary Biologicals Co. Ltd

INN (International Name) Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

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Ultifend ND IBD