Ultifend ND IBD

Country: European Union

Language: Slovak

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:

Imunologická liečba

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:

oprávnený

Authorization date:

2021-04-20

Patient Information leaflet

                                1
PRÍLOHA I
SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
2
1.
NÁZOV VETERINÁRNEHO LIEKU
Ultifend ND IBD koncentrát a rozpúšťadlo na injekčnú suspenziu
pre kurčatá
2.
KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE
Každá dávka (0,05 ml alebo 0,2 ml) obsahuje:
ÚČINNÁ LÁTKA:
Rekombinantný morčací herpes vírus (rHVT / ND / IBD), živý
exprimujúci fúzny proteín vírusu
pseudomoru hydiny asociovaný s bunkovým systémom a proteín VP2
vírusu infekčnej burzitídy:
4 000 - 12 000 PFU *
* PFU: plakotvorné jednotky
Úplný zoznam pomocných látok je uvedený v časti 6.1.
3.
LIEKOVÁ FORMA
Koncentrát a rozpúšťadlo na injekčnú suspenziu.
Koncentrát: žltohnedý homogénny koncentrát
Rozpúšťadlo: číry, oranžový až červený roztok
4.
KLINICKÉ ÚDAJE
4.1
CIEĽOVÉ DRUHY
Kurčatá a embryonované vajcia kurčiat.
4.2
INDIKÁCIE NA POUŽITIE SO ŠPECIFIKOVANÍM CIEĽOVÝCH DRUHOV
Na aktívnu imunizáciu jednodňových kurčiat alebo 18-dňových
embryonovaných vajec kurčiat:
• na redukciu mortality, klinických príznakov a lézií
vyvolaných vírusom pseudomoru hydiny (NDV)
a zníženie šírenia vírusu,
• na redukciu klinických príznakov a lézií burzy spôsobené
veľmi virulentným vírusom infekčnej
burzitídy (IBDV)
• na redukciu mortality, klinických príznakov a lézií
spôsobených vírusom Marekovej choroby
(MDV).
Nástup imunity:
Brojlerové kurčatá:
NDV: v 4 týždňoch života
IBDV: v 3 týždňoch života
MDV: v 9 dňoch života
Nosnice:
NDV: v 4 týždňoch života
IBDV: v 4 týždňoch života
MDV: v 9 dňoch života
Trvanie imunity:
Brojlerové kurčatá:
NDV: 9 týždňov
IBDV: v 9 týždňov
MDV: doživotne
3
Nosnice:
NDV: 18 týždňov
IBDV: 9 týždňov
MDV: doživotne
4.3
KONTRAINDIKÁCIE
Nie sú.
4.4
OSOBITNÉ UPOZORNENIA PRE KAŽDÝ CIEĽOVÝ DRUH
Vakcinovať len zdravé zvieratá.
4.5
OSOBITNÉ BEZPEČNOSTNÉ OPATRENIA NA POUŽÍVANIE
Osobitné bezpečnostné opatrenia na používanie u zvierat
Vakcinovať všetky kurčatá v kŕdli súčasne.
N
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRÍLOHA I
SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
2
1.
NÁZOV VETERINÁRNEHO LIEKU
Ultifend ND IBD koncentrát a rozpúšťadlo na injekčnú suspenziu
pre kurčatá
2.
KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE
Každá dávka (0,05 ml alebo 0,2 ml) obsahuje:
ÚČINNÁ LÁTKA:
Rekombinantný morčací herpes vírus (rHVT / ND / IBD), živý
exprimujúci fúzny proteín vírusu
pseudomoru hydiny asociovaný s bunkovým systémom a proteín VP2
vírusu infekčnej burzitídy:
4 000 - 12 000 PFU *
* PFU: plakotvorné jednotky
Úplný zoznam pomocných látok je uvedený v časti 6.1.
3.
LIEKOVÁ FORMA
Koncentrát a rozpúšťadlo na injekčnú suspenziu.
Koncentrát: žltohnedý homogénny koncentrát
Rozpúšťadlo: číry, oranžový až červený roztok
4.
KLINICKÉ ÚDAJE
4.1
CIEĽOVÉ DRUHY
Kurčatá a embryonované vajcia kurčiat.
4.2
INDIKÁCIE NA POUŽITIE SO ŠPECIFIKOVANÍM CIEĽOVÝCH DRUHOV
Na aktívnu imunizáciu jednodňových kurčiat alebo 18-dňových
embryonovaných vajec kurčiat:
• na redukciu mortality, klinických príznakov a lézií
vyvolaných vírusom pseudomoru hydiny (NDV)
a zníženie šírenia vírusu,
• na redukciu klinických príznakov a lézií burzy spôsobené
veľmi virulentným vírusom infekčnej
burzitídy (IBDV)
• na redukciu mortality, klinických príznakov a lézií
spôsobených vírusom Marekovej choroby
(MDV).
Nástup imunity:
Brojlerové kurčatá:
NDV: v 4 týždňoch života
IBDV: v 3 týždňoch života
MDV: v 9 dňoch života
Nosnice:
NDV: v 4 týždňoch života
IBDV: v 4 týždňoch života
MDV: v 9 dňoch života
Trvanie imunity:
Brojlerové kurčatá:
NDV: 9 týždňov
IBDV: v 9 týždňov
MDV: doživotne
3
Nosnice:
NDV: 18 týždňov
IBDV: 9 týždňov
MDV: doživotne
4.3
KONTRAINDIKÁCIE
Nie sú.
4.4
OSOBITNÉ UPOZORNENIA PRE KAŽDÝ CIEĽOVÝ DRUH
Vakcinovať len zdravé zvieratá.
4.5
OSOBITNÉ BEZPEČNOSTNÉ OPATRENIA NA POUŽÍVANIE
Osobitné bezpečnostné opatrenia na používanie u zvierat
Vakcinovať všetky kurčatá v kŕdli súčasne.
N
                                
                                Read the complete document

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 IBD Turkey herpes virus, strain Newcastle disease, infectious bursal

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Ultifend ND IBD