GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR SUSPENSION FOR NEBULISATION FOR CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Available from:

Merial Animal Health Limited

ATC code:

QI01AD07

INN (International Name):

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Dosage:

4.0 %

Pharmaceutical form:

Tablets Effervescent

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Avian infectious bronchitis virus vaccine

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2016-02-19

Summary of Product characteristics

                                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 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, 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.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy birds sho
                                
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