Gallivac IBD S706 NEO Effervescent tablet 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:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD09

INN (International Name):

Avian infectious bursal disease virus, live

Dosage:

.

Pharmaceutical form:

Effervescent tablet

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:

2021-01-08

Summary of Product characteristics

Health Products Regulatory Authority
08 January 2021
CRN00974V
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallivac IBD S706 NEO Effervescent tablet for use in drinking water
for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
​
Active substances: ​ ​
​
Infectious Bursal Disease virus, attenuated strain S706
​10
4.0
to 10
5.3
CCID50*
​
*CCID50: Cell Culture Infective Dose 50% ​ ​
​
​
​
​
Excipients: ​
​
​
​
​
Excipient
​​qs 1 dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet for suspension
Beige to pale orange, round tablet
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.
Onset of immunity: 2 weeks after the first administration.
Duration of immunity: immunity has been shown under field conditions
to persist throughout the rearing period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only
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
Care should be taken during resuspension of the vaccine and drinking
water application. Hands should be washed and
disinfected after vaccinating.
Health Products Regulatory Authority
08 January 2021
CRN00974V
Page 2 of 4
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