POULVAC BURSA PLUS LYOPHILISATE FOR SUSPENSION IN DRINKING WATER

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Last ned Preparatomtale (SPC)
12-06-2017

Aktiv ingrediens:

LIVE INFECTIOUS BURSAL DISEASE VIRUS STRAIN V877

Tilgjengelig fra:

Zoetis Ireland Limited

ATC-kode:

QI01AD09

INN (International Name):

LIVE INFECTIOUS BURSAL DISEASE VIRUS STRAIN V877

Legemiddelform:

Lyophilisate for suspension

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Fowl - Chicken

Terapeutisk område:

avian infectious bursal disease virus (gumboro disease)

Indikasjoner:

Immunological - Live Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-12-09

Preparatomtale

                                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
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