GALLIVAC IB88 NEO effervescent tablet for suspension for nebulisation for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live attenuated coronavirus, CR88121 strain

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD07

INN (International Name):

Live attenuated coronavirus, CR88121 strain

Dosage:

.

Pharmaceutical form:

Effervescent tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

avian infectious bronchitis virus

Authorization status:

Authorised

Authorization date:

2016-02-19

Summary of Product characteristics

Health Products Regulatory Authority
11 December 2020
CRN009X4S
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IB88 NEO effervescent tablet for suspension for nebulisation
for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Attenuated Infectious Bronchitis coronavirus, strain CR88121 (793B),
at least
4.0 log
10
EID
50
Excipient
…………………………………………………………
q.s. 1 dose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet for suspension for nebulisation.
Light beige, mottled, round tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens from 1 day of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduces clinical signs and lesions of respiratory disease caused by
the coronavirus variant, strain CR88 (793B) in broiler
chickens.
Immunity has been demonstrated 21 days after vaccination.
Duration of immunity: 6 weeks after vaccination.
4.3 CONTRAINDICATIONS
In the absence of trial data, future layers or breeders and chickens
in lay must not be vaccinated.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
GALLIVAC IB88 NEO vaccination does not replace the vaccination
schedule against classical Infectious Bronchitis.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy birds should be vaccinated.
The vaccinal virus can spread to non-vaccinated birds, but no trend
towards reversion to virulence was demonstrated in
laboratory trials.
Nevertheless, care should be taken to prevent spread of vaccine virus
to susceptible birds such as replacement layers and
young birds.
It is recommended to vaccinate all chickens on a site at the same
time.
Special precautions to be taken by the person administering the
veterinary medicinal product to the animals
Care should be taken during dissolution and administration of the
vaccine. During preparation of the vaccine suspension and
administration by coarse spray, the operator should wear resp