Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
live attenuated avian infectious bronchitis virus variant strain 4-91
Intervet International BV
QI01AD07
live attenuated vaccine against avian infectious bronchitis
Chicken
IMMUNOLOGICALS FOR AVES
Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Revision: 13
Authorised
1998-06-08
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL – LYOPHILISATE CUPS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB 4-91 2. QUANTITY OF ACTIVE SUBSTANCE Live IBV, 4-91 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-100 spheres) 4. ROUTE(S) OF ADMINISTRATION See package leaflet. 5. WITHDRAWAL PERIOD(S) 6. BATCH NUMBER . Lot 7. EXPIRY DATE EXP 8. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: NOBILIS IB4-91 LYOPHILISATE FOR SUSPENSION FOR CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB 4-91 lyophilisate for suspension for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Live attenuated infectious bronchitis virus variant strain 4-91: 3.6 log 10 EID 50 * per dose * EID 50 : 50% embryo infective dose - the titre required to infect 50% of the embryos inoculated with the virus. Lyophilisate Vials: off-white/cream-coloured pellet. Cups: off-white, predominantly sphere shaped. 4. INDICATION(S) Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS In laboratory studies and field trails: Vaccination with Nobilis IB 4-91 may very commonly induce mild respiratory signs of disease which may persist for a few days depending on the health and condition of the chickens. In post marketing experience: In very rare cases mild respiratory signs of disease are reported. The frequency of adverse reactions is defined using the following convention: - very commo Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB 4-91 lyophilisate for suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: 3.6 log 10 EID 50 * * EID 50 : 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension Vials: off-white/cream-coloured pellet Cups: off-white, predominantly sphere shaped 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated. Wash and disinfect hands and equipment after vaccinating to avoid spread of the virus. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines. The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area. Care should be taken to avoid the introduction of the variant strain into an area where it is not present. 3 Care should be taken to avoid spread of the vaccine virus from vaccinated chickens to pheasants. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of spray administration, personal protective equipment consisting of masks with eye protection sh Lestu allt skjalið