Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)
Intervet International BV
QI01AA23
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7
Chicken; Ducks
Immunologicals for aves
For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown.
Revision: 2
Withdrawn
2007-05-14
Medicinal product no longer authorised 15 B. PACKAGE LEAFLET Medicinal product no longer authorised 16 PACKAGE LEAFLET FOR: NOBILIS INFLUENZA H7N1 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 H7N1 Emulsion of 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 H7N1 subtype (strain, A/CK/Italy/473/99), 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 and ducks against avian influenza type A, subtype H7N1. Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals. -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown. Medicinal product no longer authorised 17 5. CONTRAINDICATIONS None. 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. Supportive data in duck Pročitajte cijeli dokument
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 H7N1 emulsion for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains: ACTIVE SUBSTANCE: Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), 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 list of excipients see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens and ducks 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1. Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals. -In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. -In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination. Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This vaccine has been tested for safety in chickens and only 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 level of efficacy a Pročitajte cijeli dokument