GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR SUSPENSION FOR NEBULISATION FOR CHICKENS

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

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Produktens egenskaper Produktens egenskaper (SPC)
15-04-2017

Aktiva substanser:

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Tillgänglig från:

Merial Animal Health Limited

ATC-kod:

QI01AD07

INN (International namn):

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Dos:

4.0 %

Läkemedelsform:

Tablets Effervescent

Receptbelagda typ:

POM

Terapeutisk grupp:

Fowl - Chicken

Terapiområde:

Avian infectious bronchitis virus vaccine

Terapeutiska indikationer:

Immunological - Live Vaccine

Bemyndigande status:

Authorised

Tillstånd datum:

2016-02-19

Produktens egenskaper

                                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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