POULVAC IB QX LYOPHILISATE FOR SUSPENSION FOR SPRAY FOR CHICKENS

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN L1148

Fáanlegur frá:

Zoetis Ireland Limited

ATC númer:

QI01AD07

INN (Alþjóðlegt nafn):

LIVE ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN L1148

Skammtar:

Unknown

Lyfjaform:

Lyophilisate for suspension for oculonasal or spray app

Gerð lyfseðils:

POM

Meðferðarhópur:

Fowl - Chicken

Lækningarsvæði:

Avian infectious bronchitis virus vaccine

Ábendingar:

Immunological - Live Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2013-09-06

Vara einkenni

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/02/2016_
_CRN 7018625_
_page number: 1_
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 taken to prevent spreading to wildlife.
Cleaning and disinfection of the premises after vaccination is advisable.
This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically
relevant.
It is important to avoid introduction of the IB QX vaccine virus i