Gallivac IBD S706 NEO

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bursal disease virus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI01AD09

INN (International Name):

Infectious bursal disease virus

Pharmaceutical form:

Effervescent tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2020-12-15

Summary of Product characteristics

Issued December 2020
AN: 00732/2019
Page 1 of 5
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 substance:
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
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
Issued December 2020
AN: 00732/2019
Page 2 of 5
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 dissolution 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
consider