Cevac IBird vakcina A.U.V.
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
10-01-2013
Summary of Product characteristics
(SPC)
10-01-2013
Active ingredient:
Infectious Bronchitis Virus 2.8 EID50/dose
Available from:
CEVA Santé Animale
ATC code:
QI
Pharmaceutical form:
Oral lyophilisate
Therapeutic group:
IMMUNOLOGICALS
Therapeutic area:
Chicken Broilers, Chicken Layers
Authorization date:
2013-05-29
Patient Information leaflet
_French agency for food, environnemental and occupational health safety_
_– French Agency for Veterinary Medicinal Products _
La Haute Marche
– Javené BP 90203 - 35302 Fougères Cédex - Téléphone : + 33 (0)2 99 94 78 78 - Télécopie : + 33 (0)2 99 94 78 99 -
w w w.anses.fr
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS
8 RUE CLAUDE BOURGELAT
PARC D'ACTIVITÉS DE LA GRANDE MARCHE - JAVENÉ
CS 70611
35306 FOUGÈRES
FRANCE
DECENTRALISED PROCEDURE
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
Cevac IBird
FR/V/0245/001/DC
Ceva
Application for Decentralised Procedure
PUBLICLY AVAILABLE ASSESSMENT REPORT
2/8
MODULE 1
PRODUCT SUMMARY
EU Procedure number
FR/V/0245/001/DC
Name, strength and
pharmaceutical form
Cevac IBird
Lyophilisate for suspension for reconstitution in
water
Applicant
CEVA- Phylaxia veterinary Biologicals Co. Ltd
Active substance(s)
Live Infectious Bronchitis Virus, strain 1/96
ATCvet code
QI01AD07
Target species
Chickens
Indication for use
For the active immunization of broiler chickens,
and future layer chickens in order to reduce the
impact on the ciliary activity of the infection,
which may be manifested in respiratory clinical
signs caused by variant strains of infectious
bronchitis virus belonging to the 793/B group_ _
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the website
http://www.anmv.anses.fr/
[http://www.anmv.anses.fr/]
MODULE 3
PUBLIC ASSESSMENT REPORT
Legal basis of original
application
Decentralised application in accordance with
Article 31 of Directive 2001/82/EC as amended.
Read the complete document
Summary of Product characteristics
1
_[Version 7.3.2, 10/2011] _
_Cevac IBird P1B English 2013-05-28 clean _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC IBird lyophilisate for suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Live, attenuated infectious bronchitis (IB) virus, strain 1/96,
min. 2.8 log10 EID50* /dose
max. 4.3 log10 EID50* /dose
EXCIPIENTS:
q.s. 1 dose
*EID50 =50 %Embryo infective dose: the virus titre required to produce infection in 50% of the
embryos inoculated.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Yellowish white, lyophilisate for suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken (broilers and future layers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of broiler chickens, and future layer chickens in order to reduce the
detrimental effect on the ciliary activity resulting from the infection, which may be manifested in
respiratory clinical signs. Protection was demonstrated by challenge with the 793/B strain, which is a
representative strain of the 793/B group.
Onset of immunity is 3 weeks after one administration of the vaccine.
Duration of immunity is 6 weeks after the first vaccination.
4.3
CONTRAINDICATIONS
Do not vaccinate unhealthy animals.
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
All chickens on a site should be vaccinated at the same time and within the same premises.
The vaccine strain may spread to
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