Avishield IB H120, lyophilisate for oculonasal suspension/use in drinking water, for chickens

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Avian infectious brochitis virus massachusetts serotype strain h-120

Commercializzato da:

GENERA Inc

Codice ATC:

QI01AD07

INN (Nome Internazionale):

Avian infectious brochitis virus massachusetts serotype strain h-120

Dosaggio:

.

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:

Chickens

Area terapeutica:

avian infectious bronchitis virus

Indicazioni terapeutiche:

Immunological - Live Vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2018-02-09

Scheda tecnica

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.
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, personal protective
equipment consisting of masks with eye protection should be worn by
the operator and staff.
4.6
A