GALLIVAC IBD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Infectious bursal disease virus, attenuated strain S706

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD09

INN (International Name):

Infectious bursal disease virus, attenuated strain S706

Dosage:

.

Pharmaceutical form:

Lyophilisate for oculonasal suspension/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:

2006-12-21

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IBD
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Active ingredient:
Infectious Bursal Disease virus, attenuated strain S706, at least 10
4.0
CCID
50
Excipient:
qs 1 dose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, future layers and broiler breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to protect against mortality and to
reduce lesions associated with Infectious Bursal (Gumboro)
Disease. Immunity has been demonstrated 2 weeks after the first
administration and has been shown under field conditions to
persistthroughout the rearing period.
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy birds.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the spread of the vaccine virus, it is recommended to separate
vaccinated and unvaccinated birds.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
During spray administration, the eyes must be protected by safety
goggles and the nose and mouth by a dust mask. A helmet
with filtered air circulation may be used instead of goggles and a
mask.Care should be taken during reconstitution of the
vaccine and drinking water application. Hands should be washed and
disinfected after vaccinating.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Laboratory studies have shown that when the vaccine virus was
experimentally passed from bird to bird, damage to the bursa
increased. This was detected by histological examination of the
bursae. However, this is not considered to result in an
immunosuppressive effect.
Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 2 of 4
4.7 USE DURING PREGNANCY, LACTATION OR L