GALLIVAC IB88

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live attenuated infectious bronchitis coronavirus, (strain CR88121) (793B)

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD07

INN (International Name):

Live attenuated infectious bronchitis coronavirus, (strain CR88121) (793B)

Dosage:

4.0-5.3 log 10 50% embryo infective dose/dose

Pharmaceutical form:

Powder for nebuliser suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

avian infectious bronchitis virus

Authorization status:

Authorised

Authorization date:

2003-06-23

Summary of Product characteristics

Health Products Regulatory Authority
07 December 2018
CRN008MPY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IB88
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine 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
Powder for nebuliser suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens from 14 days 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 17 days after vaccination, and the
duration of
immunity is at least 5 weeks.
4.3 CONTRAINDICATIONS
In the absence of trial data, furure layers or breeders and chickens
in lay must not be
vaccinated.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Gallivac IB88 vaccination does not replace the vaccination schedule
against classical
Infectious Bronchitis.
Health Products Regulatory Authority
07 December 2018
CRN008MPY
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy birds should be vaccinated.
The vaccine 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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO THE ANIMALS
Care should be taken during reconstitution and administration of the
vaccine. The
operator should wear respiratory and eye protection conforming to
current European
standards. For further information contact the manufacturer.Hands
should be washed
and disinfected after vaccinating.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination may in