Ultifend ND IBD

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970
Public Assessment Report Public Assessment Report (PAR)
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:

Imunologija za aves

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:

Pooblaščeni

Authorization date:

2021-04-20

Patient Information leaflet

                                13
B. NAVODILO ZA UPORABO
14
NAVODILO ZA UPORABO
ULTIFEND ND IBD KONCENTRAT IN VEHIKEL ZA SUSPENZIJO ZA INJICIRANJE ZA
PIŠČANCE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za
sproščanje serij:
Ceva-Phylaxia Co. Ltd.
1107 Budapest, Szállás u. 5.
Madžarska
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Ultifend ND IBD koncentrat in vehikel za suspenzijo za injiciranje za
piščance
3.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN
Vsak odmerek (0,05 ml ali 0,2 ml) vsebuje:
UČINKOVINA(E):
Celično vezan živ rekombinantni puranji herpesvirus (rHVT/ND/IBD),
ki izraža fuzijski protein virusa
atipične kokošje kuge in VP2 protein virusa bolezni Gumboro:
min. 4.000, max. 12.000 PFU*
*enote, ki tvorijo plak
Koncentrat: rumenkasto rjav, homogen koncentrat
Vehikel: bistra, oranžna do rdeča raztopina
4.
INDIKACIJA(E)
Za aktivno imunizacijo enodnevnih piščancev ali 18-dnevnih
embrioniranih kokošjih jajc:
•
za zmanjšanje smrtnosti, kliničnih znakov in lezij, povzročenih z
virusom atipične kokošje kuge
(NDV – Newcastle disease virus) in za zmanjšanje izločanja virusa,
•
za zmanjšanje smrtnosti, kliničnih znakov in burzalnih lezij, ki jih
povzroča zelo virulenten
virus bolezni Gumboro (IBDV – infectious bursal disease virus)
•
za zmanjšanje smrtnosti, kliničnih znakov in lezij, povzročenih s
klasičnim virusom Marekove
bolezni (MDV – Marek's disease virus).
Nastop imunosti:
Brojlerji
NDV: 4 tedni
IBDV: 3 tedni
MDV: 9 dni
Nesnice
NDV: 4 tedni
IBDV: 4 tedni
MDV 9 dni
Trajanje imunosti:
Brojlerji
NDV: 9 tednov
15
IBDV: 9 tednov
MDV: celo življenjsko dobo
Nesnice
NDV:18 tednov
IBDV: 9 tednov
MDV: celo življenjsko dobo
5.
KONTRAINDIKACIJE
Jih ni.
6.
NEŽELENI UČINKI
Niso znani.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso
navedeni v tem navodilu za uporabo ali
mislite, da zdravilo ni delovalo, obvestite svojega ve
                                
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Summary of Product characteristics

                                1
_ _
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Ultifend ND IBD koncentrat in vehikel za suspenzijo za injiciranje za
piščance
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsak odmerek (0,05 ml ali 0,2 ml) vsebuje:
UČINKOVINA(E):
Celično vezan živ rekombinantni puranji herpesvirus (rHVT/ND/IBD),
ki izraža fuzijski protein virusa
atipične kokošje kuge in VP2 protein virusa bolezni Gumboro:
min. 4.000, max. 12.000 PFU*
*enote, ki tvorijo plak
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Koncentrat in vehikel za suspenzijo za injiciranje
Koncentrat: rumenkasto rjav homogen koncentrat
Vehikel: bistra, oranžna do rdeča raztopina
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Piščanci in embrionirana kokošja jajca.
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Za aktivno imunizacijo enodnevnih piščancev ali 18-dnevnih
embrioniranih kokošjih jajc:
•
za zmanjšanje smrtnosti, kliničnih znakov in lezij, povzročenih z
virusom atipične kokošje kuge
(NDV – Newcastle disease virus) in za zmanjšanje izločanja virusa,
•
za zmanjšanje smrtnosti, kliničnih znakov in burzalnih lezij, ki jih
povzroča zelo virulenten
virus bolezni Gumboro (IBDV – infectious bursal disease virus)
•
za zmanjšanje smrtnosti, kliničnih znakov in lezij, povzročenih s
klasičnim virusom Marekove
bolezni (MDV – Marek's disease virus).
Nastop imunosti:
Brojlerji
NDV: 4 tedni
IBDV: 3 tedni
MDV: 9 dni
Nesnice
NDV: 4 tedni
IBDV: 4 tedni
MDV 9 dni
Trajanje imunosti:
Brojlerji
NDV: 9 tednov
IBDV: 9 tednov
MDV: celo življenjsko dobo
3
Nesnice
NDV:18 tednov
IBDV: 9 tednov
MDV: celo življenjsko dobo
4.3
KONTRAINDIKACIJE
Jih ni.
4.4.
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Cepite samo zdrave živali.
Nastop imunosti za IBDV pri piščancih z visoko vsebnostjo
maternalnih protiteles proti IBDV ali
MDV je lahko zakasnjen za približno en teden, če je cepljenje
opravljeno s tem zdravilom za uporabo
v veterinarski medicini
                                
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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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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
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Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
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Alerts Ultifend IBD Turkey herpes virus, strain Newcastle disease, infectious bursal

Ultifend IBD Turkey herpes virus, strain Newcastle disease, infectious bursal

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Ultifend ND IBD