Poulvac Bursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Infectious bursal disease virus strain lukert

Available from:

Zoetis Belgium S.A.

ATC code:

QI01AD09

INN (International Name):

Infectious bursal disease virus strain lukert

Dosage:

tissue culture infective dose 50/dose

Pharmaceutical form:

Lyophilisate for oculonasal suspension/use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

avian infectious bursal disease virus (gumboro disease)

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2015-09-18

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac
Bursine 2 lyophilisate for suspension for spray vaccination or for use
in drinking water for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCES:
Live attenuated Infectious Bursal Disease virus strain Lukert:
≥10
4.3
TCID
50
*
*TCID
50
= 50% tissue culture infective dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for spray vaccination or for use in
drinking water.
Beige to mid-brown, lyophilized.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers and future layers/breeders).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of broilers, and future layers/breeders to
reduce clinical signs caused by
Infectious Bursal Disease virus.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Maternally derived antibodies (MDA) can interfere with the development
of active immunity. Where
it is likely that recent field infection or vaccination of the parent
flock has stimulated a high antibody
titre and consequently a high level of MDA, the timing of the
vaccination programme should be
planned accordingly.
Very virulent Infectious Bursal Disease virus can breakthrough higher
maternal antibody levels than
vaccine virus.
Field infection is capable therefore of reaching birds before vaccine
has a chance to take. Only use as
part of a complete Infectious Bursal Disease control programme
involving hygiene, biosecurity,
management, stocking density and disinfection, etc. Overwhelming
levels of field virus may overcome
vaccinal immunity.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The vaccine virus can spread to in contact birds.
Care should be taken to ensure that the vaccine virus does not spread
to unvaccinated birds. It is
recommended to vaccinate all chickens on a site at the same time.
Cleaning and disin