Poulvac Bursa Plus
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-05-2013
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Active ingredient:
live infectious bursal disease virus,strain GM97 10 mg
Available from:
Fort Dodge Animal Health
ATC code:
QI01AD09
Pharmaceutical form:
Oral suspension
Therapeutic group:
Avian infectious bursal disease virus (Gumboro disease)
Therapeutic area:
Chicken Broilers
Authorization date:
2011-04-08
Summary of Product characteristics
Revised: July 2013
AN: 00576/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac Bursa (DK)
Poulvac Bursa Plus vakcina A.U.V. (HU)
Poulvac Bursa Plus (all other countries)
Lyophilisate for suspension in drinking water.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Per dose
Live Infectious Bursal Disease Virus, strain V877 10
2.2
- 10
3.4
EID
50
*
*
50% egg infective dose
EXCIPIENTS
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension in drinking water.
Appearance : brownish tablets.
4.
CLINICAL PARTICULARS
4.0
TARGET SPECIES
Chickens, from 10 days of age.
4.1
INDICATIONS FOR USE
For the active immunisation of chickens with maternal antibody levels of ≤ 500
ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
The onset of immunity has been shown by challenge from 14 days after
vaccination and the duration of immunity is 32 days.
4.2
CONTRA-INDICATIONS
Do not vaccinate sick birds.
Do not use in infected flocks showing clinical signs.
4.3
SPECIAL WARNINGS
Use only in flocks with maternal antibody levels of ≤ 500 ELISA units. The
optimum day of vaccination is calculated according to the Kouwenhoven’s
formula (see section 4.5. Special precautions for use).
Due to its residual pathogenicity to the bursae the vaccine should be used
only in case of outbreaks of very virulent IBDV strains.
Revised: July 2013
AN: 00576/2012
Page 2 of 5
4.4
SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE I
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