POULVAC BURSA PLUS LYOPHILISATE FOR SUSPENSION IN DRINKING WATER

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

LIVE INFECTIOUS BURSAL DISEASE VIRUS STRAIN V877

Disponible des:

Zoetis Ireland Limited

Codi ATC:

QI01AD09

Designació comuna internacional (DCI):

LIVE INFECTIOUS BURSAL DISEASE VIRUS STRAIN V877

formulario farmacéutico:

Lyophilisate for suspension

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Fowl - Chicken

Área terapéutica:

avian infectious bursal disease virus (gumboro disease)

indicaciones terapéuticas:

Immunological - Live Vaccine

Estat d'Autorització:

Authorised

Data d'autorització:

2013-12-09

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac Bursa Plus Lyophilisate for suspension in drinking water
.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate for suspension in drinking water.
Appearance : brownish tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens, from 10 days of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
Do not vaccinate sick birds.
Do not use in infected flocks showing clinical signs.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
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
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
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_7_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_2_
_5_
_2_
_0_
_p_
_a_
_g_
_e_
_