Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Infectious Bronchitis Virus 2.8 EID50/dose
CEVA Santé Animale
QI
Oral lyophilisate
IMMUNOLOGICALS
Chicken Broilers, Chicken Layers
2013-05-29
_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
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 Read the complete document