Poulvac Bursa Plus Lyophilisate for suspension in drinking water

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Live infectious bursal disease virus, strain V877

Tilgjengelig fra:

Zoetis Belgium S.A.

ATC-kode:

QI01AD09

INN (International Name):

Live infectious bursal disease virus, strain V877

Dosering :

.

Legemiddelform:

Lyophilisate for use in drinking water

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Chickens

Terapeutisk område:

avian infectious bursal disease virus (gumboro disease)

Indikasjoner:

Immunological - Live Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-12-09

Preparatomtale

Health Products Regulatory Authority
11 October 2017
CRN000TZY
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac Bursa Plus 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 the full list of excipients, see section 6.1
​
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.
Health Products Regulatory Authority
11 October 2017
CRN000TZY
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
I)SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use carefully as Poulvac Bursa Plus spreads from bird to bird and may
also spread to
nearby flocks. Reversion to virulence studies conducted at the
laboratory level
demonstrated that there is no increase in virulence after 5 passages
in chickens.
However, it is recommended to avoid spreading, especially to laying
birds.
The optimum age for vaccination may be determined with the following
method:
Determine the ELISA* antibody titres against Gumboro Disease in