Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)
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.Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Revision: 8
Authorised
2006-09-01
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: NOBILIS INFLUENZA H5N2 EMULSION FOR INJECTION 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 Influenza H5N2 emulsion of injection for chickens. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 0.5 ml contains: ACTIVE SUBSTANCE: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log 2 as tested according to the potency test. ADJUVANT: Liquid light paraffin: 234.8 mg. 4. INDICATION(S) For active immunisation of chickens against avian influenza type A, subtype H5. Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination. Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine. 5. CONTRAINDICATIONS Do not administer intramuscularly in chickens less than 2 weeks old. 6. ADVERSE REACTIONS A transient diffuse swelling may very commonly occur at the vaccination site, which persists for about 14 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) 17 - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you think th Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N2 emulsion for injection for chickens. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5 ml contains: ACTIVE SUBSTANCE: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log 2 as tested according to the potency test. ADJUVANT: Liquid light paraffin 234.8 mg EXCIPIENTS: For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. White homogeneous emulsion. 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. Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine. 4.3 CONTRAINDICATIONS Do not administer intramuscularly in chickens less than 2 weeks old. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This vaccine has been tested for safety in chickens. 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 attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None. 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 produ Izlasiet visu dokumentu