Ultifend ND IBD

Country: European Union

Language: Danish

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:

Immunologicals for 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:

autoriseret

Authorization date:

2021-04-20

Patient Information leaflet

                                14
B. INDLÆGSSEDDEL
15
INDLÆGSSEDDEL:
ULTIFEND ND IBD KONCENTRAT OG SOLVENS TIL INJEKTIONSVÆSKE,
SUSPENSION, TIL KYLLINGER
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for
batchfrigivelse:
Ceva-Phylaxia Co. Ltd.
1107 Budapest, Szállás u. 5.
Ungarn
2.
VETERINÆRLÆGEMIDLETS NAVN
Ultifend ND IBD koncentrat og solvens til injektionsvæske,
suspension, til kyllinger
3.
ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
Hver dosis (0,2 ml eller 0,05 ml) rekonstitueret vaccine indeholder:
Celleassocieret levende, rekombinant kalkunherpesvirus (rHVT/ND/IBD),
der udtrykker
fusionsprotein fra Newcastle disease virus og VP2 proteinet fra
infektiøs bursal sygdom (IBD) virus:
min. 4000, max. 12000 PFU*.
*
Plaque Forming Unit
.
Koncentrat: gulligbrunt homogent cellekoncentrat.
Solvens: klar, orangerød opløsning
4.
INDIKATIONER
Til aktiv immunisering af daggamle kyllinger eller æg med 18 dage
gamle kyllingeembryoner:
- For at reducere mortalitet og kliniske symptomer og læsioner
forårsaget af Newcastle disease virus
(NDV) og samt reducere virus spredning.
- For at reducere mortalitet samt reducere kliniske symptomer og bursa
læsioner forårsaget af meget
virulent infektiøs bursal sygdom virus (IBDV).
- For at reducere mortalitet, kliniske symptomer og læsioner
forårsaget af klassisk Mareks disease
virus (MDV).
Indtræden af immunitet:
Slagtekyllinger
NDV: 4-uger
IBDV: 3-uger
MDV: 9 dage
Kommende æglæggende høns
NDV: 4-uger
IBDV: 4-uger
MDV: 9 dage
Varighed af immunitet:
Slagtekyllinger
NDV: 9-uger
IBDV: 9-uger
16
MDV: livslang
Kommende æglæggende høns
NDV: 18 uger
IBDV: 9 uger
MDV: livslang
5.
KONTRAINDIKATIONER
Ingen
6.
BIVIRKNINGER
Ingen kendte.
Kontakt din dyrlæge, hvis du observerer bivirkninger. Dette gælder
også alvorlige bivirkninger, der
ikke allerede er anført i denne indlægsseddel, eller hvis du 
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
VETERINÆRLÆGEMIDLETS NAVN
Ultifend ND IBD koncentrat og solvens til injektionsvæske,
suspension, til kyllinger
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver dosis (0,05 ml eller 0,2 ml) indeholder:
AKTIVT STOF:
Celleassocieret levende, rekombinant kalkunherpesvirus (rHVT/ND/IBD)
der udtrykker
fusionsproteinet fra Newcastle disease virus og VP2 proteinet fra
infektiøs bursal sygdom (IBD) virus:
min. 4000, max. 12000 PFU
*
*PFU: Plaque Forming Units
Alle hjælpestoffer er anført under pkt. 6.1
3.
LÆGEMIDDELFORM
Koncentrat og solvens til injektionsvæske, suspension.
Koncentrat: gulligbrunt homogent cellekoncentrat.
Solvens: klar, orange til rød opløsning
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Kyllinger og embryonerede hønseæg.
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Til aktiv immunisering af daggamle kyllinger eller æg med 18 dage
gamle kyllingeembryoner:
- For at reducere mortalitet, kliniske symptomer og læsioner
forårsaget af Newcastle disease virus
(NDV) samt reducere virusudskillelse.
- For at reducere mortalitet samt reducere kliniske symptomer og
bursalæsioner forårsaget af meget
virulent infektiøs bursal sygdom virus (IBDV).
- For at reducere mortalitet, kliniske symptomer og læsioner
forårsaget af klassisk Marek’s disease
virus (MDV).
Indtræden af immunitet:
Slagtekyllinger
NDV: 4 uger
IBDV: 3 uger
MDV: 9 dage
Kommende æglæggende høns: NDV: 4 uger
IBDV: 4 uger
MDV: 9 dage
Varighed af immunitet:
Slagtekyllinger
NDV: 9-uger
IBDV: 9-uger
MDV: livslang
3
Kommende æglæggende høns
NDV:-18 uger
IBDV: 9-uger
MDV: livslang
4.3
KONTRAINDIKATIONER
Ingen.
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Kun raske dyr må vaccineres.
Indtræden af immunitet for IBD hos kyllinger med meget højt niveau
af maternelle antistoffer mod
IBDV eller MDV kan være forsinket med omkring en uge efter
vaccination med dette veterinære
lægemiddel.
4.5
SÆRLIGE F
                                
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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
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
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Public Assessment Report Public Assessment Report Spanish 01-01-1970
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Ultifend ND IBD