CEVAC MASS L LYOPHILISATE FOR OCULONASAL SUSPENSION FOR CHICKEN

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

IB VIRUS MASSACHUSETTS TYPE, B48 STRAIN

Fáanlegur frá:

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

ATC númer:

QI01AD07

INN (Alþjóðlegt nafn):

IB VIRUS MASSACHUSETTS TYPE, B48 STRAIN

Skammtar:

Unknown

Lyfjaform:

Lyophilisate for suspension

Gerð lyfseðils:

POM

Meðferðarhópur:

Fowl - Chicken

Lækningarsvæði:

Avian infectious bronchitis virus vaccine

Ábendingar:

Immunological - Live Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2016-05-20

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC MASS L lyophilisate for oculonasal suspension for chicken
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
Chicken
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens 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: 6 weeks following vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 20/05/2016_
_CRN 7022336_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy animals only.
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 medi