GALLIVAC IB88

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

INFECTIOUS BRONCHITIS CORONAVIRUS, STRAIN CR88121 LIVE ATTENUATED

Available from:

Merial Animal Health Limited

ATC code:

QI01AD07

INN (International Name):

INFECTIOUS BRONCHITIS CORONAVIRUS, STRAIN CR88121 LIVE ATTENUATED

Dosage:

4.0-5.3

Pharmaceutical form:

Powder for suspension for nebulization

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Avian infectious bronchitis virus vaccine

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2003-06-23

Summary of Product characteristics

                                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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/06/2012_
_CRN 7012796_
_page number: 1_
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
                                
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