Avishield IBD Plus, lyophilisate for use in drinking water, for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Avian infectious bursal disease virus, live

Available from:

GENERA Inc

ATC code:

QI01AD09

INN (International Name):

Avian infectious bursal disease virus, live

Dosage:

.

Pharmaceutical form:

Lyophilisate for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

avian infectious bursal disease virus (gumboro disease)

Authorization status:

Authorised

Authorization date:

2020-06-26

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2020
CRN00923J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield IBD Plus, lyophilisate for use in drinking water, for
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains
ACTIVE SUBSTANCE:
Attenuated live Infectious Bursal Disease virus, Intermediate plus
strain G6 10
1.9
- 10
3.2
EID
50
*
*EID
50
= 50% embryo infective dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for use in drinking water.
Cream to red-brown coloured lyophilisate.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, future layers and breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens (broilers, future layers and
breeders) with maternally derived antibodies (break-through
titre: ≤500 IDEXX ELISA units) to reduce clinical disease and bursal
lesions due to infection caused by Avian Infectious Bursal
Disease (IBD) viruses.
Chickens can be vaccinated from 10 days of age.
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 5 weeks after vaccination
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
See 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
following vaccination for at least 5 days. The spread does
not induce clinical signs.
It is possible that the vaccine virus spreads 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 bird to
bird transmission. Vaccinated birds should not be mixed
with unvaccinated birds. Hygiene measures should be taken to prevent
spread to other flocks. Vaccination of all chickens on
the premises is recommended. Housing needs to be disinfected prior to
resto