Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water, for chickens

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Avian infectious bursal disease virus, live

Tilgængelig fra:

GENERA Inc

ATC-kode:

QI01AD09

INN (International Name):

Avian infectious bursal disease virus, live

Dosering:

.

Lægemiddelform:

Lyophilisate for oculonasal suspension/use in drinking water

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

avian infectious bursal disease virus (gumboro disease)

Autorisation status:

Authorised

Autorisation dato:

2019-01-07

Produktets egenskaber

Health Products Regulatory Authority
17 January 2019
CRN000WS3
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield IBD INT, lyophilisate for oculonasal suspension/use in
drinking water, for
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains
​
ACTIVE SUBSTANCE:
​
​
Attenuated live Infectious Bursal Disease virus,
​
​
IM strain VMG 91
​
10
4.0
to 10
5.0
TCID
50
*
*TCID
50
= 50% tissue culture infective dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water
Cream to reddish coloured lyophilisate
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens (broilers, future layers and
breeders), with
maternally derived antibodies, to prevent mortality and clinical
disease, due to
infection caused by Avian Infectious Bursal Disease viruses.
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 4 weeks after vaccination
4.3 CONTRAINDICATIONS
None.
Health Products Regulatory Authority
17 January 2019
CRN000WS3
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please refer to section 4.9.
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The vaccine strain can spread to susceptible, unvaccinated chickens
for at least 10
days following vaccination. The vaccine virus has shown the potential
to increase in
virulence on bird to bird passage and may cause immunosuppression but
does not
induce clinical signs of disease. It is very important to take
measures to ensure that
the vaccine strain does not spread to unvaccinated chickens.
It is possible that the vaccine viruses can be spread to non-target
susceptible species.
Care should be taken to ensure that the vaccine virus does not spread
to
unvaccinated birds. Therefore, all birds in a flock should be
vaccinated at the same
time to reduce the risk of bi