国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
live avian infectious bronchitis virus, strain D388
Intervet International B.V.
QI01AD07
avian infectious bronchitis virus strain D388
Chicken
Live viral vaccines, Domestic fowl
For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus.
Revision: 5
Authorised
2014-09-04
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - LYOPHILISATE CUPS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB Primo QX 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Live IBV, D388 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-400 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. 17 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL - SOLVENT VIALS 1. NAME OF THE VETERINARY PRODUCT Solvent Oculo/Nasal 2. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 35 ml 3. ROUTE OF ADMINISTRATION Read the vaccine package before use. 4. STORAGE CONDITIONS Store below 25 °C. Do not freeze. 5. BATCH NUMBER Lot 6. EXPIRY DATE EXP 7. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: NOBILIS IB PRIMO QX LYOPHILISATE AND SOLVENT FOR OCULONASAL SUSPENSION FOR CHICKENS NOBILIS IB PRIMO QX LYOPHILISATE FOR OCULONASAL SUSPENSION FOR CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, 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 Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of reconstituted vaccine contains: Live attenuated avian infectious bronchitis virus, strain D388: 10 4.0 – 10 5.5 EID 50 1 1 50% egg infective dose. Lyophilisate: Off white, predominantly sphere shaped. Solvent (Solvent Oculo/Nasal): blue-coloured solution. 4. INDICATION(S) For 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live attenuated avian infectious bronchitis virus, strain D388: 10 4.0 – 10 5.5 EID 50 1 1 50% egg infective dose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension. Lyophilisate: Off white, predominantly sphere shaped. Solvent (Solvent Oculo/Nasal): blue-coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV). Onset of immunity: 3 weeks. Duration of immunity: 8 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens. Precautionary measures should be taken to prevent spreading to wildlife. The premises must be cleaned and disinfected after each production round. This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant. It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present. The IB D388 vaccine should only be applied in 3 hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks. The vaccine has been demonstr 完全なドキュメントを読む