Cevac Meta L lyophilisate for oculonasal suspension for chickens

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Avian metapneumovirus, subtype B, CRR126 strain

Commercializzato da:

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

Codice ATC:

QI01AD01

INN (Nome Internazionale):

Avian metapneumovirus, subtype B, CRR126 strain

Dosaggio:

.

Forma farmaceutica:

Lyophilisate for oculonasal suspension/use in drinking water

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Chickens

Area terapeutica:

avian rhinotracheitis virus

Indicazioni terapeutiche:

Immunological - Live Vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-11-11

Scheda tecnica

Health Products Regulatory Authority
01 October 2021
CRN00C48L
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevac Meta L lyophilisate for oculonasal suspension for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
​
Live, attenuated avian metapneumovirus_, _subtype B, strain CRR126
​2.5-3.8 log10 TCID
50
*
*TCID
50
= 50% Tissue culture infective dose: the virus titre required to
produce infection in 50% of the tissue culture inoculated.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension
Yellowish white lyophilisate
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of future layer chickens in order to reduce
respiratory signs and virus shedding associated with
infection by avian metapneumovirus which is known to be the primary
etiological agent of Swollen Head Syndrome.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 9 weeks after vaccination.
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Vaccinated chickens may excrete the vaccine strain up to 20 days
following vaccination.
The vaccine strain can spread to unvaccinated birds.
In order to reduce the chance of circulation of the vaccine strain, it
is recommended to vaccinate all susceptible animals on a
site, preferably at the same time
Appropriate veterinary and husbandry measures, such as cleaning and
disinfection, should be taken to avoid spread of the
vaccine strain to susceptible species.
Unvaccinated birds should be separated from vaccinated chickens.
Health Products Regulatory Authority
01 October 2021
CRN00C48L
Page 2 of 4
Turkeys in contact with vaccinated chickens may react to the vaccine
strain and show clinical signs such as slight sneezing or
conjunctivitis, which may