POULVAC BURSINE 2 VACCINE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-06-2015
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Active ingredient:
BURSAL DISEASE VIRUS STRAIN LUKERT
Available from:
Zoetis Ireland Limited
ATC code:
QI01AD09
INN (International Name):
BURSAL DISEASE VIRUS STRAIN LUKERT
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate for suspension
Prescription type:
POM
Therapeutic area:
Avian infectious bursal disease virus vaccine (Gumboro disease)
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2014-05-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac Bursine 2 Vaccine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate for suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens from one day of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the vaccination of broilers, rearing birds, future layers and breeding birds to reduce clinical signs caused by
Gumboro Disease.
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy birds.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Maternally-derived antibody (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 gumboro virus can breakthrough higher maternal antibody levels than the vaccine virus. Field infection is
capable therefore of reaching birds before vaccine has a chance to take. Only use as part of a complete gumboro control
programme involving hygiene, biosecurity, management, stocking density and disinfection, etc. Overwhelming levels
of field virus may overcome vaccinal immunity.
The virus of the vaccine will spread to unvaccinated birds.
ACTIVE SUBSTANCES (PER DOSE)
Infectious bursal disease virus strain Lukert >10
4.3
TCID
50
EXCIPIENT(S)
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 10/06/2015_
_CRN 7021081_
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING TH
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