POULVAC IB QX LYOPHILISATE FOR SUSPENSION FOR SPRAY FOR CHICKENS

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN L1148

Commercializzato da:

Zoetis Ireland Limited

Codice ATC:

QI01AD07

INN (Nome Internazionale):

LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN L1148

Forma farmaceutica:

Lyophilisate for suspension for oculonasal or spray app

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Fowl - Chicken

Area terapeutica:

avian infectious bronchitis virus

Indicazioni terapeutiche:

Immunological - Live Vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-09-06

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac IB QX lyophilisate for suspension for spray for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
Live attenuated Avian Infectious Bronchitis Virus, strain L1148
10
3.0
–10
5.0
EID
50
*
* EID50 = 50 % Embryo Infective Dose.
EXCIPIENT:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension for spray.
Off-white, beige coloured. Upon reconstitution, transparent to white
opaque suspension (depending on the volume of
diluent used).
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens in order to reduce respiratory
signs of Infectious Bronchitis caused by QX-like
variants of Infectious Bronchitis virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 63 days after vaccination.
4.3 CONTRAINDICATIONS
Do not vaccinate future layers/breeders before 1 week of age.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine virus is capable of spreading to in contact birds for a
minimum of 14 days after vaccination and
appropriate care should be taken to separate vaccinated from
non-vaccinated chickens. Precautionary measures should
be