Novamune concentrate and solvent for suspension for injection for chickens

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Avian infectious bursal disease virus, live

Beschikbaar vanaf:

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

ATC-code:

QI01AD09

INN (Algemene Internationale Benaming):

Avian infectious bursal disease virus, live

Dosering:

.

farmaceutische vorm:

Concentrate and solvent for suspension for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

avian infectious bursal disease virus (gumboro disease)

Autorisatie-status:

Authorised

Autorisatie datum:

2018-08-31

Productkenmerken

Health Products Regulatory Authority
26 July 2021
CRN00C99T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Novamune concentrate and solvent for suspension for injection for
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) contains:
​
ACTIVE SUBSTANCE:
​
​
Live attenuated IBD virus, Serotype 1, strain SYZA26
​2.5 – 4.2 log10 CID50*
​
​
​
EXCIPIENTS:
​
​
BDA (Bursal Disease Antibody)
1.3 – 2.2 log10 AB unit**​
For the full list of excipients, see section 6.1.
* Chicken Infective Dose 50%
** Antibody unit
3 PHARMACEUTICAL FORM
Concentrate and solvent for suspension for injection.
Vaccine concentrate: reddish-brownish frozen suspension.
Solvent: clear, orange to red liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of day-old future layer chickens in order to
reduce clinical signs and acute lesions of bursa of Fabricius
caused by very virulent Avian Infectious Bursal Disease (IBD) virus
infection.
Onset of immunity is expected from 30 days depending on the initial
MDA level.
The immunisation is influenced by the natural decline of maternally
derived antibodies (MDA), and has been found to occur
when MDA have reached appropriate release level. The onset of clinical
protection depends on the initial MDA level. In
vaccinated day old future layer chicks the release of the vaccine
virus (vaccine virus take) was observed between 21-42 days
after vaccination.
Duration of immunity: 9 weeks.
The virulent challenge tests conducted to support the claim were
carried out on day old future layer chicks having MDA ELISA
titre of 3,000 to 5,700 (average Day 0 MDA levels).
Field trials carried out showed that vaccine virus replication in the
bursa of Fabricius occurs in day old future layer chicks having
average MDA titre levels of 6,000 ELISA units.
4.3 CONTRAINDICATIONS
Do not vaccinate chickens from non-vaccinated parent flocks or having
no MDA against IBDV