Cevac Mass L Lyophilisate for Oculonasal Suspension for Chicken

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Infectious bronchitis virus

Commercializzato da:

Ceva Animal Health Ltd

Codice ATC:

QI01AD07

INN (Nome Internazionale):

Infectious bronchitis virus

Forma farmaceutica:

Nebulisation solution

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Chickens

Area terapeutica:

Live Viral Vaccine

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2016-05-26

Scheda tecnica

Revised: October 2022
AN: 01551/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC MASS L lyophilisate for oculonasal suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) contains:
ACTIVE SUBSTANCE:
Live, attenuated infectious bronchitis virus (IBV), Massachusetts B-48
strain
10
2.8
-
10
4.3
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.
Yellowish pellet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers and future layers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of broilers and future layers against
infectious bronchitis
(Massachusetts serotype), in order to reduce respiratory clinical
signs, detrimental
effect on the ciliary activity and presence of virus in the trachea.
Protection was demonstrated by challenge with the Massachusetts M41
strain.
Onset of immunity: 3 weeks following vaccination.
Duration of immunity: 9 weeks following vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: October 2022
AN: 01551/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated chickens may excrete the vaccine strain for up to 28 days
following
vaccination.
During this time, special precautions should be taken to avoid
spreading of the vaccine
strain to unvaccinated chickens and to other bird species, if any are
close by.
All chickens within the same farm should be vaccinated before or when
entering the
premises.
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 a mask with eye
protectio