Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
Intervet International BV
QI01AA23
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Chicken
Immunologicals for aves
For active immunisation of chickens against avian influenza type A, subtype H5.Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Revision: 1
Withdrawn
2008-01-31
Medicinal product no longer authorised 15 B. PACKAGE LEAFLET Medicinal product no longer authorised 16 PACKAGE LEAFLET FOR: NOBILIS INFLUENZA H5N6 EMULSION FOR INJECTION 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Manufacturer for the batch release: Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6 Emulsion for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) On dose of 0.5 ml contains: Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥6.0 log 2 as tested according to the potency test. Adjuvant: Liquid paraffin 4. INDICATION For active immunisation of chickens against avian influenza type A, subtype H5. Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination. Serum antibodies have been shown to persist in chickens for at least 7 months. Studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. 5. CONTRAINDICATIONS None. Medicinal product no longer authorised 17 6. ADVERSE REACTIONS Safety has been assessed on the basis of results in chickens. A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Chickens. 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION For subcutaneous or intramuscular use. _Chickens _ From 8-14 days old: 0.25 ml subcutaneously From 14 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 Influenza H5N6 emulsion for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains: ACTIVE SUBSTANCE: Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥6.0 log 2 as tested according to the potency test. ADJUVANT: Liquid light paraffin 234.8 mg/0.5 ml For a full 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 active immunisation of chickens against avian influenza type A, subtype H5. Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination. Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains. This vaccine has been tested for safety in chickens. and some supportive data for safety in ducks are available. If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination. The level of efficacy for other species may differ from that observed in chickens. The vaccine has been shown to induce antibodies in ducks to the homologous virus by four weeks after two doses and these persist for at least six months but the Lire le document complet