GALLIVAC IB88 NEO effervescent tablet for suspension for nebulisation for chickens

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Live attenuated coronavirus, CR88121 strain

Dostępny od:

Merial Animal Health Limited

Kod ATC:

QI01AD07

INN (International Nazwa):

Live attenuated coronavirus, CR88121 strain

Dawkowanie:

4.0-5.3 log 10 50% embryo infective dose

Forma farmaceutyczna:

Effervescent tablet

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Chickens

Dziedzina terapeutyczna:

avian infectious bronchitis virus

Wskazania:

Immunological - Live Vaccine

Status autoryzacji:

Authorised

Data autoryzacji:

2016-02-19

Charakterystyka produktu

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