Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91
Intervet International BV
QI01AB07
adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A
Chicken
Immunologicals for aves
For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved. Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.,
Revision: 7
Withdrawn
2003-01-24
Medicinal product no longer authorised 15 B. PACKAGE LEAFLET Medicinal product no longer authorised 16 PACKAGE LEAFLET Nobilis OR inac emulsion for injection for chickens 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA Marketing authorisation holder and manufacturer: Intervet International Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis OR inac emulsion for injection for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 0.25 ml: Inactivated whole cell suspension of _Ornithobacterium rhinotracheale_ serotype A strain B3263/91 1 x 10 7 cells * * inducing a mean titre in the chickens of the potency test of at least 11.2 (log 2 ). Light liquid paraffin: 107.21 mg Traces of formaldehyde 4. INDICATION(S) For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with _Ornithobacterium rhinotracheale_ serotype A when this agent is involved. Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching. 5. CONTRAINDICATIONS Do not use for birds in lay 6. ADVERSE REACTIONS In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination. Under field conditions, sporadic local and systemic clinical reactions have been reported. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Medicinal product no longer authorised 17 7. TARGET SPECIES Chickens 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single dose of 0.25 ml. Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken. 9. ADVICE ON CORRECT ADMINISTRATION Lire le document complet
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis OR inac emulsion for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.25 ml: ACTIVE SUBSTANCE Inactivated whole cell suspension of _Ornithobacterium rhinotracheale_ serotype A, strain B3263/91 1 x 10 7 cells * * inducing a mean titre in the chickens of the potency test of at least 11.2 (log 2 ). ADJUVANT Light liquid paraffin: 107.21 mg EXCIPIENTS Traces of formaldehyde For a list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with _Ornithobacterium rhinotracheale_ serotype A when this agent is involved. Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching. 4.3 CONTRAINDICATIONS Do not use in birds in lay. 4.4 SPECIAL WARNINGS None Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Allow vaccine to reach room temperature (15-25°C) before using the vaccine. Shake well before use. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS To the user: This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for mo Lire le document complet