POULVAC BURSINE 2 LYOPHILISATE FOR SUSPENSION FOR SPRAY VACCINATION OR FOR USE IN DRINKING WATER FOR CHICKENS

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

INFECTIOUS BURSAL DISEASE VIRUS STRAIN LUKERT

Dostupné z:

Zoetis Ireland Limited

ATC kód:

QI01AD09

INN (Medzinárodný Name):

INFECTIOUS BURSAL DISEASE VIRUS STRAIN LUKERT

Forma lieku:

Lyophilisate for suspension

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Fowl - Chicken

Terapeutické oblasti:

avian infectious bursal disease virus (gumboro disease)

Terapeutické indikácie:

Immunological - Live Vaccine

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-09-18

Súhrn charakteristických

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
ACTIVE SUBSTANCES PER DOSE:
Infectious bursal Disease virus strain Lukert:
10
4.3
– 10
5.5
TCID
50
EXCIPIENTS:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension.
Brown to reddish brown lyophilisate.
Upon reconstitution, light peach to a tan-brownish suspension
depending on volume of water added.
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
Do not vaccinate unhealthy birds.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
The virus of the vaccine will spread to unvaccinated birds.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__