Avishield IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water, for Chickens

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Infectious bronchitis virus

Disponibil de la:

Genera Inc.

Codul ATC:

QI01AD07

INN (nume internaţional):

Infectious bronchitis virus

Forma farmaceutică:

Lyophilisate for oculonasal suspension/use in drinking water

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Chickens

Zonă Terapeutică:

Live Viral Vaccine

Statutul autorizaţiei:

Authorized

Data de autorizare:

2018-02-13

Caracteristicilor produsului

Revised: June 2023
AN: 01938/2022 & 01945/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield IB H120, lyophilisate for oculonasal suspension/use in
drinking water, for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains
ACTIVE SUBSTANCE:
Attenuated live virus of avian infectious bronchitis,
Massachusetts serotype, strain H-120
10
3.5
to 10
4.5
EID
50
*
_*EID_
_50_
_ = 50% Embryo infective dose _
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water
Cream coloured lyophilisate
4.
CLINICAL INFORMATION
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens in order to reduce the detrimental
effect resulting
from the infection by avian infectious bronchitis virus, serotype
Massachusetts on the
ciliary activity, which may be manifested in respiratory clinical
signs.
Onset of immunity:
3 weeks after vaccination
Duration of immunity: 8 weeks after vaccination
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: June 2023
AN: 01938/2022 & 01945/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
All the birds in the flock should be vaccinated at the same time.
The vaccine strain can spread to susceptible, unvaccinated chickens
for a minimum
of 10 days following vaccination. It is possible that the vaccine
virus can be spread to
non-target susceptible species. Appropriate veterinary and husbandry
measures
should be taken to avoid spread of the vaccine strain to unvaccinated
birds or
susceptible species as much as possible.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Care should be taken when reconstituting and administering the vaccine
. Wash and
disinfect hands and equipment after administration of the vaccine.
When spraying the
vaccine,